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CTRI Number  CTRI/2014/08/004874 [Registered on: 13/08/2014] Trial Registered Retrospectively
Last Modified On: 11/07/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A Prospective study to assess the correct depth of insertion of endotracheal tubes during nasal and oral intubation in the Indian population 
Scientific Title of Study   A Prospective study to assess the correct depth of insertion of endotracheal tubes during nasal and oral intubation in the Indian population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Mumbai
MAHARASHTRA
400012
India 
Phone  022241777050  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Mumbai
MAHARASHTRA
400012
India 
Phone  022241777050  
Fax    
Email  sheila150@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sheila Nainan Myatra 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Mumbai
MAHARASHTRA
400012
India 
Phone  022241777050  
Fax    
Email  sheila150@hotmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, 
 
Primary Sponsor  
Name  Dr Sheila Nainan Myatra 
Address  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India  
Type of Sponsor  Other [Academic Funding of the Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sheila Nainan Myatra  Tata Memorial Centre  Department of Anaesthesia, Critical Care, Pain. Tata Memorial Centre, Dr. E. Borges Road Mumbai-400-012,India
Mumbai
MAHARASHTRA 
022241777050

sheila150@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient should be: More than 18 years of age ASA I and II Under General Anaesthesia Oral or nasal intubation Giving consent ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endotracheal Intubation with fiberscope  Endotracheal Intubation is a commonly performed procedure in the operating room to maintain the airway and respiration in patients receiving general anaesthesia. Endotracheal tubes are passed both through the oral route and nasal route depending on the type of surgery. Serious complications can occur from if the tube is too far inside and enters the mainstem bronchus, such as hypoxaemia caused by atelectasis formation in the unventilated lung and hyperinflation and barotrauma with development of a pneumothorax of the intubated lung. If the tube is too far out it there can be an accidental extubation. Hence, proper positioning of the endotracheal tube in relation to the carina is therefore clinically important. The recommended safe position of the tip of the endotracheal tube in the trachea is 2.5 to 4 cms.above the carina1 .This positioning can however be checked and done only by using a flexible fiberscope in OT and is not practical in routine clinical practice. 
Comparator Agent  Endotracheal Intubation with other surrogate methods  Various surrogate methods are used in clinical practice to confirm the safe distance of ETT from the carina. The most commonly used methods are— 1. Visual inspection of symmetrical chest rise - visually inspecting the bilateral symmetrical movement of active chest rise and passive fall. 2. Palpation of symmetrical chest rise-resting the palm over sternum and fanning fingers over both side of the chest and palpating movement of chest during inspiration and expiration. 3. Bilateral auscultation (5 point auscultation) - proper position of endotracheal tube can also be confirmed by bilaterally auscultation of air entry at five areas over the chest wall. 4. Estimation of correct position by the insertion depth/marking at the level of incisors -Another method is securing orally placed tracheal tubes at the upper incisor teeth (or gums) at the 23-cm mark in men and the 21-cm mark in women of average adult size. 5. Position /horizontal line on the tube at the vocal cord- placing the horizontal line at the level of vocal cord positions the distal end of the tube approximately 4 cm from the carina. 6. Sonographic confirmation of proper placement of endotracheal tube-USG(ultrasonography) can also be used to confirm whether the tube is placed endo-bronchially or endo-tracheal with presence or absence of lung slide(LS), comet tail artefact(CTA) or colour-power Doppler(CPD) along the visceral-parietal pleural interface.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  ASA I and II
Under General Anaesthesia
Oral or nasal intubation
Giving consent
 
 
ExclusionCriteria 
Details  Any respiratory pathology
Haemodynamic instability Endotracheal tube size > 7mms  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correct depth of insertion of the endotacheal tube when inserted orally and nasally in Indian patients for safe tube positioning (tip of tube 2.5 -4 cms from the carina).  I year 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether there is any correlation between the depth of insertion and heght, weight, sex, BMI of the patient  I year 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/11/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Endotracheal Intubation is a commonly performed procedure in the operating room to maintain the airway and respiration in patients receiving general anaesthesia. Endotracheal tubes are passed both through the oral route and nasal route depending on the type of surgery. Serious complications can occur from if the tube is too far inside and enters the mainstem bronchus, such as hypoxaemia caused by atelectasis formation in the unventilated lung and hyperinflation and barotrauma with development of a pneumothorax of the intubated lung. If the tube is too far out it there can be an accidental extubation. Hence, proper positioning of the endotracheal tube in relation to the carina is therefore clinically important. The recommended safe position of the tip of the endotracheal tube in the trachea is 2.5 to 4 cms.above the carina1 .This positioning can however be checked and done only by using a flexible fiberscope in OT and is not practical in routine clinical  practice.

 

Other methods are available in clinical practice to check proper tube position .Institutions like the American Heart Association and the European Resuscitation Council and major textbooks on anaesthesia recommend bilateral auscultation of the chest to diagnose and prevent endobronchial intubation and this has been the conventional practice. Brunel et al, however, found that 60% of endobronchial intubations in patients in despite equal breath sounds on examination.2 Other additional clinical tests to verify correct positioning have therefore become routine, including observation of symmetrical chest movements, palpation of symmetrical chest expansion, and use of the cm scale printed on the endotracheal tube. 3,4

 

Recently a prospective blinded study published in BMJ was conducted to determine which bedside method of detecting inadvertent endobronchial intubation in adults has the highest sensitivity and specificity. The sensitivity and specificity for ruling out endobronchial intubation with auscultation alone was 65% and 93% respectively ,with observation was 43% and 90 % respectively and using depth of tube insertion was 88% and 98% respectively. Hence among the methods depth of insertion of tube was found to be most sensitive and specific. When all 3 methods were combined the sensitivity was 100% and the specificity was 95%.5 This study looked at only oral intubations and the optimal tube insertion depth was found be 20 cm in females and 22 cm in males (20/22 formula)

 

This study showed that auscultation alone is inadequate for assessment of proper position of endotracheal tube and that checking for symmetrical chest movements is of little use. The hierarchy of the methods used to assess the correct insertion depth should be changed and clinicians should rely more on depth insertion than on auscultation. The study showed that both experienced and inexperienced physicians wouldl benefit from using a 20/22 cm formula for depth of tube insertion while using oral tubes.

 

One of the limitations of the study was that it was done in a relatively smaller number of patients and also only in a western population .The depth of tube insertion may also depend on the length of the trachea and the distance from the nose /mouth upto the vocal cords which may be dependent on the height and weight of the patients .Hence the 20/22 cm formula for oral intubations may require modification for populations that have larger or smaller height.

 

There is not much literature available about the depth of insertion of the endotracheal tube while doing nasal intubations. An old study using nasal intubations 6 showed that at 26 cm in women and 28 cm in men, measured at the naris, resulted in adequate initial placement for most adult patients. However the numbers in this study were very small and the safe distance from the tip of the tube to the carina was considered as 2 cms which is an old recommendation and no longer accepted. This study was also done in western population.

 

We would like to do a prospective study in a large number of patients using the current recommendation for depth of insertion of endotracheal tube when passed orally (20/22 cms.) and nasally (26/28 cms) and see whether it can be applicable to Indian patient.

 

Our aim is to determine the correct depth of insertion of endotracheal tubes during nasal and oral intubation in the Indian population and determine whether there is any co-relation with the height, weight, sex and BMI of the patient. The gold standard for determining the exact position of the tube in the trachea in OT is by measuring it using a flexible fiberscope.

 
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