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A Comparative Study of Early and Late Tracheostomy in Patients Requiring Prolonged Tracheal Intubation

Authors:  Kiran Bylappa (1)*, Azeem Mohiyudin (2)**, Wilma Delphine
Silvia CR (3)***, Dinesh Krishnamurthy (4)**, Mohammed Shabbir Pyarajan (5)*

*Assistant Professor, **Professor, ***Professor and Head of Department

Institutions:  

(1) Dept. of Otorhinolaryngology, Sapthagiri Institute of Medical Sciences
& Research Center, Bengaluru -560090, Karnataka, India
(2) Dept. of Otorhinolaryngology, Sri Devaraj Urs Medical College, Tamaka,
Kolar, 563 101, Karnataka, India
(3) Department of Biochemistry, Sapthagiri Institute of Medical Sciences &
Research Center, Bengaluru, 560090, Karnataka, India.
(4) Department of Anesthesia, Sri Devaraj Urs Medical College, Tamaka,
Kolar, 563 101, Karnataka, India
(5) Department of Emergency Medicine, PES Medical College, Kuppam, Chittor
District - 517425, India

Corresponding Author: 

Dr. Wilma Deplhine Silvia CR
Professor & Head,
Department of Biochemistry,
Sapthagiri Institute of Medical Sciences & Research Centre, Bangalore-560090, India.
Email: widel2008@gmail.com

Abstract:

Aims and Objective:  Tracheostomy is commonly performed in the intensive care unit for patients requiring prolonged intubation.  The ideal time for performing tracheostomy is still controversial.  The aim of this study is to assess the advantages of performing early tracheostomy (5 to 7 days) in comparison to late tracheostomy (8 to 15 days) with regard to weaning from a ventilator, mucosal injury to the pharynx, larynx and trachea and length of stay in the hospital.  

Subjects and Methods:  This is a comparative, clinical evaluation study which is comprised of 44 patients who required prolonged tracheal intubation while admitted in the intensive care unit.  The study's subjects were divided into two groups of either sex, each group consisting of 22 patients.  Group A: Early tracheostomy (5-7 days) and Group B: Late tracheostomy (8-15 days).   Based on subject's dependence on mechanical ventilator for 4 days after intubation, and projected to need mechanical ventilation for at least 6 more days were randomly assigned to Group A (early tracheostomy - 5-7 days).  For those patients not assigned to Group A, and who were still ventilated at 8 days, the subjects were assigned to Group B (late tracheostomy - 8-15 days).    

Results:  The patients in both the groups were followed every two weeks after discharge and at the end of the third month, for evaluation for mucosal injury to pharynx, larynx and trachea and detection of other complications.  Early tracheostomy required a shorter duration of mechanical ventilator support 4-5 days P<0.001 when compared to late tracheostomy 5-9 days p<0.001 and early tracheostomy facilitated early weaning.  There was a high incidence of aspiration and hypostatic pneumonia in late tracheostomy groups (59%) compared to early tracheostomy (18%) with P<0.002.  The duration of the hospital stay was also significantly longer in Group B compared to Group A (39.14 verses 30.95 days) with P<0.001.    

Conclusion:  We concluded that, early tracheostomy was associated with a shorter duration of mechanical ventilatory support and thus it may facilitate early weaning, a shorter stay in the hospital and making it more cost effective compared to late tracheostomy.  Further studies on large populations are required to substantiate early tracheostomy is more effective compared to late tracheostomy.    

 
Introduction:

Prolonged tracheal intubation is frequently required for the patients in an intensive care unit (ICU) for various reasons including assisted ventilation, protection of airway, and tracheo-bronchial toilet.1,2  Tracheal intubation can be done by either an endotracheal tube (nasal or oral), or by tracheostomy.  Insertion of an endotracheal tube does not require surgery.  However, it can cause ulceration and injury to the pharynx, larynx and trachea.  It limits the patient's movements who are bedridden and involves the phonatary part of the larynx (glottis), and is associated with loss of speech during that period.  It predisposes the patients to subglottic stenosis which is difficult to manage.3

Tracheostomy is an invasive surgical procedure.  It can be associated with complications.  However, they are less common since the tracheotomy tube bypasses the subglottis.   The subglottis is the narrowest part of the airway and the region where complications are likely to arise.4  It avoids injury to the pharynx and larynx, and facilitates the patient's mobility and communication.  It reduces the dead space and ventilatory efforts and makes tracheobronchial toilet easier.5  The ideal time to perform tracheostomy has been a controversial topic.  Even though this is a commonly performed surgery, there is no definite standard of care as to when it should be done.6

In 1989, the National Association of Medical Directors of Respiratory Care recommended that translaryngeal (endotracheal) intubation be used only if artificial ventilation is required less than 10 days.  Tracheostomy should be placed in patients who require ventilation 21 days or longer.7  Although these recommendations are not evidanced based but only based on expert opinion, they are largely followed by modern day medicine.8  Various studies around the world have compared the benefits of early tracheostomy, according to the study conducted by Rodriguez, et al.,9 and Ahmed N, et al.10   Early tracheostomy was conducted on subjects within 7 days, and late tracheostomy after 7 days.9,10  But the study carried out by Terragni, et al., defines subjects as receiving an early tracheostomy after 6 to 8 days and late tracheostomy 13 to 15 days.11 

These studies found that long-term complications were fewer and survival rates were better in patients undergoing early tracheostomy.  However, these studies also had contradictory results with regard to mechanical ventilation, duration of hospitalization and nosocomial pneumonia.12  In a recent study, Bickenback, et al.,  found that patients who had early tracheostomy, less than or equal to 4 days, had a shorter length of ventilation, reduced ventilator associated pneumonia, reduced sepsis and shorter length of ICU stay as compared to patients with late tracheostomy (greater than or equal to 10 days).13

Hence, this present study was carried out to find out the advantages and complications of early tracheostomy (5-7 days) versus late tracheostomy (8-15 days) on patients who require prolonged tracheal intubation.  Also an attempt has been made to determine the ideal time for performing tracheostomy in patients requiring long-term intubation.  

 
Methods and Materials:
  

The study was a randomized comparative clinical trial comprised of 44 subjects ages 14 to 60 years of either sex, admitted in the intensive care unit.  Subjects included in this study required prolonged intubation due to non-corrosive poisoning, snakebites, head injuries and respiratory paralysis secondary to neurological diseases and also patients with a normal neck who were admitted to the intensive care unit for transoral endotracheal intubation.   

Patients with trauma to the neck, with previous neck surgery, tracheostomy, scar or keloid in the neck, who had radiotherapy to the neck, chemotherapy for malignancy, fungating growth in the neck, granulomatous diseases, deep neck space abscess or cellulitis of the neck, were excluded from the study.  Ethical clearance was obtained from the institution and informed consent from patient's relative was obtained.

The study's subjects were divided into two groups, each group consisting of 22 patients.  Group A: Early tracheostomy (5-7 days) and Group B: Late tracheostomy (8-15 days).   Based on subject's dependence on mechanical ventilator for 4 days after intubation, and projected to need mechanical ventilation for at least 6 more days were randomly assigned to Group A (early tracheostomy - 5-7 days).  For those patients not assigned to Group A, and who were still ventilated at 8 days, the subjects were assigned to Group B (late tracheostomy - 8-15 days).9,10,12

To eliminate bias, elective tracheostomy in the ICU and fibreoptic laryngotracheoscopy at the time of discharge, to evaluate for mucosal injury in the pharynx, larynx, and trachea, was performed by the same surgeon.  The findings were documented.  Both groups of patients were followed, every 14 days, and at the end of the third month, to look for any mucosal injury in the pharynx, larynx, and trachea, and any other complications.  Decannulation was done when the patient developed a vigorous cough and absence of aspiration.14

Surgical description of tracheostomy procedure in the intensive care unit

The tracheostomy procedure was performed in the ICU under local anesthesia with 2% xylocaine with 1:200,000 adrenaline. The patient was placed in a supine position using a head ring and shoulder bag to achieve optimal extension of neck and head at the atlanto-occipital joint.

A horizontal skin incision was placed approximately two fingers from the sternal notch or at the midpoint between the lower border of the cricoid cartilage and suprasternal notch.  The incision was deepened and layers of the neck dissected.  The strap muscles were separated in the midline until trachea was reached.  The pre-tracheal layer of fascia covering the trachea was dissected and retracted to expose the trachea.  The cricoid cartilage was palpated and stabilized using a sharp cricoid hook.   4% lignocaine was injected into the trachea to anesthetize the tracheal mucosa and to help confirm that the exposed structure was the trachea and not a major vessel. 

The trachea was opened at the level of the second to the fourth tracheal ring and the trachea was dilated using a tracheal dilator and an inferiorly based flap (Bjork Flap) was created.  A stay stitch was placed in the flap and an appropriately sized portex cuffed tracheostomy tube was inserted into the trachea and inflated.  The tube was stabilized using a strap, and the collar of the tube was sutured to the skin.  After complete hemostasis was achieved, the wound was closed with betadine.

STATISTICAL ANALYSIS
Descriptive statistical analysis was carried out on this study using a chi-square test, fisher exact test, and a student t test (Two tailed, independent).  Data analysis was carried out using statistical software namely, Statistical Package for Social Science (SPSS) 15.0.


Results:

This study was comprised of 44 subjects, with ages between 18 to 60 years with a mean age in Group A of 33.05 ± 16.35 years and in Group B being 32.86 ± 12.69 years.  There was a male predominance in both groups.  In Group A, the male-to- female ratio was 59.1% to 40.9% and in Group B the male-to-female ratio was 77.3% to 22.7%.

In this study, subjects with organophosphorus poisoning predominated in both groups, followed by road traffic accidents with head injury, cerebral malaria, septic shock, snakebite and dengue fever -- see Table 1.  The requirement of assisted ventilation was significantly reduced in the early tracheostomy group (4-5 days, P<0.001**) compared to the late tracheostomy group (5-9 days, P<0.001**) - see Table 2.  There was a high incidence of complications such as aspiration, hypostatic pneumonia, crusting, and partial tracheostomy tube block in the late tracheostomy group compared to the early tracheostomy group--see Table 3.   (** Indicates statistically highly significant.)

     Table 1 Diagnosis

Table 2:  Duration of Ventilation

Table3:  Post Tracheotomy Complications

Findings on fiberoptic laryngotracheoscopy at the time of discharge found that pharyngeal mucosal injury was more common in the late tracheostomy group as compared to the early tracheostomy group.  Laryngeal mucosal injuries, ulcerations of the epiglottis, arytenoid subluxation, laceration of the vocal cord and fixation of the vocal cord was found to be more common in the late tracheostomy group compared to the early tracheostomy group - see Figure 1.  Tracheal mucosal injury was also found to be more common in the late tracheostomy group - see Figure 2 and Table 4.  In addition, the bronchopulmonary segments showed excessive thick discharge and occasionally blood-stained secretion in the late tracheostomy group as compared to the early tracheostomy group - see Table 4.

Figure 1: Ulceration of laryngeal surface of epiglottis due to prolonged endotracheal intubation Figure 2: Ulceration of posterior and
lateral wall of trachea

Table 4:  Late Complications 

The duration of the hospital stay was found to be shorter in the early tracheostomy group as compared to the late tracheostomy group - see Table 5.  On follow up after 3 months, the fiberoptic laryngotracheoscopy findings showed better healing and fewer complications in the early tracheostomy group when compare to the late tracheostomy group - see Figure 3 (right) and Table 6.

Figure 3:  Cartilaginous type of subglottic stenosis.
 
  
   

Table 5:  Hospital Stay 

Table 6:  3 Month or More Follow Up 


Discussion:

Tracheotomy is a surgical procedure which is performed to replace endotracheal intubation in patients who are expected to require prolonged mechanical ventilation.  Tracheostomy provides early airway protection and has been found to decrease the need for prolonged mechanical ventilatory support.1-3

The majority of the subjects in this study requiried prolonged ventilation from organophosphorus poisoning.  These cases can be attributed to the fact that most of the population in this region are poor agriculturists and have easy access to organophosphorus compounds.  These patients were admitted to the ICU for treatment.  The second most common cause was road traffic accidents, due to the fact that our hospital is situated on a major national highway.  The next common cause was cerebral malaria as this area is endemic for malaria - see Table 1.

In this study, the subjects who underwent early tracheostomy (5 to 7 days) recovered earlier in contrast to subjects who underwent late tracheostomy (8 to 15 days).  In the early tracheostomy group, the patients required 4 to 5 days additional ventilatory support, whereas in the late tracheostomy group required 5 to 9 days of additional support.  This observation is explained by the fact that following tracheostomy there is a reduction of ventilatory dead space, less airway resistance and easier tracheobronchial toilet with a tracheostomy than with an endotracheal tube.   These benefits contribute to better weaning from the ventilator.  Similar findings were observed by Mitka K., et al.15  They found a reduction in the duration of mechanical ventilation favoring the early tracheostomy group compared to late tracheostomy.15  Arabi, et al., found that the duration of mechanical ventilation was significantly shorter (9.6 vs. 18.7 days) when tracheostomy was performed within 7 days compared to late tracheostomy when performed after more than 7 days.16

Our study found a high incidence of aspiration (59%) in the late tracheostomy group compared to the early tracheostomy group (14%).  This may be due to inadequate nursing care.  The complication of crusting (9.1%) and ulceration (59.1%) was also found more commonly in late tracheostomy compared to early tracheostomy group (4.5%) and (31.8%) respectively.   This may be due to the fact that prolonged pressure on the  trachea leads to ischemia and necrosis - see Table 2.  This observation has been supported by Major M., et al.17  Their study also showed that early tracheostomy reduces complications.17

Hsu CL , et al.18 found there was a reduction of ventilatory dead space and less airway resistance with a tracheostomy as compared to a translaryngeal tube.  The benefits associated with tracheostomy contributed to better weaning from ventilatory support, improved bronchial suctioning and psychological advantages for the severely ill and recovering ICU patients.18

Our study found that it takes a longer time for healing of mucosal injury (pharynx, larynx and trachea) in the late tracheostomy group as compared to the early tracheostomy group, which was documented by using fiberoptic laryngotracheoscopy at the time of discharge - see Table 4.  This finding has been supported by Santos, et al.19  In their study, 79 patients were examined laryngoscopically after prolonged oral endotracheal tube intubation.  In the study, 94% had laryngeal edema, 76% ulceration and 44% granulomas, the majority of which formed four weeks after intubation.19

Our study also observed that the length of stay in the hospital was shorter in the early tracheostomy group, the average being fewer than 30 days, in contrast to anywhere between 30 to 45 days in the case of late tracheostomy patients.  This ended up in a lower cost of hospitalization - see Table 5.  This observation has been supported by Brook, et al.20 and colleagues who showed that those subjects who underwent early tracheostomy (less than 10 days, mean 5.9 days) with that or late tracheostomy (greater than 10 days, mean 16.7 days) showed a decreased in both duration of mechanical ventilation (28.3 vs. 34.4 days) and ICU length of stay (15.6 vs. 29.3 days).  This was reflected in a lower cost of hospitalization ($86,189 vs. $124,649) for the patients who received tracheostomy within 10 days.20

Postoperative follow up after three months found that long-term complications were greater in the late tracheostomy group - see Table 4.  Due to the small sample size, with the exception of excessive blood stained secretions, complications did not individually reach scientific significance but did so when considered as a group.  These complications in the late tracheostomy group included arytenoid subluxation (13.6%) (during endotracheal tube intubation) and granuloma at tracheostomy (32%), compared to the early tracheostomy group which had arytenoid subluxation (4.5%) and granuloma at tracheostomy (18.2%).  Three patients developed postoperative dyspnea secondary to subglottic stenosis, two in the late tracheostomy group (9%) and one in the early tracheostomy group - see Figure 3 and Table 6. 

Table 6 shows data on a cartilaginous type of subglottic stenosis secondary to stomal infection or prolonged intubation.  There were two patients with this finding in the late tracheostomy group and one patient in the early tracheotomy group.  Although our data does not reach the level of scientific significance, this observation has been supported by Bouderka, et al.,21 in their study of 150 patients on follow up with fiberoptic laryngotracheoscopy.  In the late tracheostomy group, they found five patients with inflammatory granuloma, one patient with tracheal stenosis compared to one patient with inflammatory granuloma in the early tracheostomy group.  In the late tracheostomy group, three patients presented with stridor, and one in the early tracheostomy group.21

Based on the above evidence and literature review, we advocate performance of early tracheostomy within 5 to 7 days after endotracheal intubation, as opposed to late tracheostomy, since it has been observed to reduce the risk of major complications and facilitate early weaning off the ventilator.  It also minimizes the duration of hospitalization leading to more cost effective care.

Conclusion:

We would like to conclude that early tracheostomy produces a shorter duration of mechanical ventilatory support.  Thus, it facilitates early weaning, a shorter stay in the hospital and decreased cost compared to late tracheostomy.

 
References:

1. Scales DC, Ferguson ND. Early vs late tracheotomy in ICU patients. JAMA. 2010 Apr 21;303(15):1537-8.   View Abstract

2. De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. Epub 2007 Jun 27.   View Abstract

3. Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8.   View Abstract

4. Kluge S, Baumann HJ, Maier C, Klose H, Meyer A, Nierhaus A, Kreymann G. Tracheostomy in the intensive care unit: a nationwide survey. Anesth Analg. 2008 Nov;107(5):1639-43.   View Abstract

5. Boubaker C, Abdelhamid H, Abdellatif B, et al. Tracheotomy versus prolonged intubation in medical intensive care unit.  Signa vitae 2009;4(1):21-3.

6. Boynton JH, Hawkins K, Eastridge BJ, et al. Tracheostomy timing and the duration of weaning in patients with acute respiratory failure. Critical care. 2004 Aug;8:R261-7.   View Article

7. Plummer AL, Gracey DR. Consensus conference on artificial airways in patients receiving mechanical ventilation. Chest. 1989 Jul;96(1):178-80.   View Article

8. Fischler L, Erhart S, Kleger GR, Frutiger A. Prevalence of tracheostomy in ICU patients. A nation-wide survey in Switzerland. Intensive Care Med. 2000 Oct;26(10):1428-33.    View Article

9. Rodriguez JL, Steinberg SM, Luchetti FA, Gibbons KJ, Taheri PA, Flint LM. Early tracheostomy for primary airway management in the surgical critical care setting. Surgery. 1990 Oct;108(4):655-9.   View Article

10. Ahmed N, Kuo YH. Early versus late tracheostomy in patients with severe traumatic head injury. Surg Infect (Larchmt). 2007 Jun;8(3):343-7.  View Article

11. Terragni PP, Antonelli M, Fumagalli R, Faggiano C, Berardino M, Pallavicini FB, Miletto A, Mangione S, Sinardi AU, Pastorelli M, Vivaldi N, Pasetto A, Della Rocca G, Urbino R, Filippini C, Pagano E, Evangelista A, Ciccone G, Mascia L, Ranieri VM. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010 Apr 21;303(15):1483-9.   View Article

12. Rumbak MJ, Newton M, Truncale T, Schwartz SW, Adams JW, Hazard PB. A prospective, randomized, study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Crit Care Med. 2004 Aug;32(8):1689-94.   View Article

13. Bickenbach J, Fries M, Offermanns V, Von Stillfried R, Rossaint R, Marx G, Dembinski R. Impact of early vs. late tracheostomy on weaning: a retrospective analysis. Minerva Anestesiol. 2011 Dec;77(12):1176-83. Epub 2011 May 26.  View Abstract  

14. Christopher KL. Tracheostomy decannulation. Respir Care. 2005 Apr;50(4):538-41.  View Abstract

15. Mitka K, Soulountsi V, Houris I, Massa E, et al. Early versus late tracheotomy in the ICU. Critical Care. 2008 Mar;12(Suppl 2): P-331.   View Abstract

16. Arabi Y, Haddad S, Shirawi N, Al Shimemeri A. Early tracheostomy in intensive care trauma patients improves resource utilization: a cohort study and literature review. Crit Care. 2004 Oct;8(5):R347-52. Epub 2004 Aug 23.   View Article

17. Major KM, Hui T, Wilson MT, Gaon MD, Shabot MM, Margulies DR. Objective indications for early tracheostomy after blunt head trauma. Am J Surg. 2003 Dec;186(6):615-9; discussion 619.    View Article

18. Hsu CL, Chen KY, Chang CH, Jerng JS, Yu CJ, Yang PC. Timing of tracheostomy as a determinant of weaning success in critically ill patients: a retrospective study. Crit Care. 2005 Feb;9(1):R46-52. Epub 2004 Dec 23.  View Article

19. Santos PM, Afrassiabi A, Weymuller EA Jr. Risk factors associated with prolonged intubation and laryngeal injury. Otolaryngol Head Neck Surg. 1994 Oct;111(4):453-9.   View Article

20. Brook AD, Sherman G, Malen J, Kollef MH. Early versus late tracheostomy in patients who require prolonged mechanical ventilation. Am J Crit Care. 2000 Sep;9(5):352-9.   View Article 

21.Bouderka MA, Fakhir B, Bouaggad A, Hmamouchi B, Hamoudi D, Harti A. Early tracheostomy versus prolonged endotracheal intubation in severe head injury. J Trauma. 2004 Aug;57(2):251-4.   View Article
 

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