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
|
|
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
|
|
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. |