CTRI Number |
CTRI/2022/04/041671 [Registered on: 05/04/2022] Trial Registered Prospectively |
Last Modified On: |
20/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective |
Study Design |
Single Arm Study |
Public Title of Study
|
To check the movement of airway tube after placing patient head in position for head and neck cancer surgery |
Scientific Title of Study
|
To measure the extent of endotracheal tube migration after placement of patient in optimal surgical
position for primary head and neck onco-surgeries – A prospective, observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Seema |
Designation |
Senior Resident |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
Department of Anesthesia, Third floor, hospital block, AIIMS Bhopal
Bhopal MADHYA PRADESH 462020 India |
Phone |
9652688582 |
Fax |
|
Email |
sapre7seema@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vaishali Waindeskar |
Designation |
Professor |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
Department of Anesthesia, Third floor, Hospital block, AIIMS Bhopal
Bhopal MADHYA PRADESH 462020 India |
Phone |
9575604490 |
Fax |
|
Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
Name |
Seema |
Designation |
Senior Resident |
Affiliation |
All India Institute of Medical Sciences, Bhopal |
Address |
Department of Anesthesia, third floor, Hospital block, AIIMS, Bhopal
Bhopal MADHYA PRADESH 462020 India |
Phone |
9652688582 |
Fax |
|
Email |
sapre7seema@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Seema |
Address |
Department of Anesthesia , AIIMS Bhopal |
Type of Sponsor |
Other [Self] |
|
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 |
Seema |
All India Institute of Medical Sciences, Bhopal |
Third floor, Hospital block, Saket nagar, Bhopal, Madhya Pradesh, 462020 Bhopal MADHYA PRADESH |
9652688582
sapre7seema@gmail.cpm |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing head and neck onco-surgeries requiring nasotracheal intubation |
|
ExclusionCriteria |
Details |
1. Patients in whom nasotracheal intubation is contraindicated
2. Patients in whom glottic view is sub-optimal through opposite nostril
3. Inability to pass FOB through the opposite nostril.
4. Restricted neck movement and extension
5. ASA Grade III and above
|
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
1)Displacement of endotracheal tube at vocal cords with head and neck extension and lateral rotation
2)Depth of ETT at nares with head and neck in neutral position
|
Assessment will be done at a single time point. Intra-operatively. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Length of trachea with head and neck in neutral position and with neck extended. |
single measurement will be taken after intubation intra-operatively |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
11/04/2022 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
12/12/2023 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Nasotracheal (NT) intubation is commonly performed in patients undergoing head and neck surgeries, such as intraoral, dental, or microlaryngeal procedures or mandibulectomies. Malpositioned tube can cause endobronchial intubation if too deep or accidental extubation, vocal cord damage if too shallow.1,2 Previous studies have suggested that the proximal cuffs of NT tubes should be placed >2 cm3,4 or at 3 cm5 below the vocal cords to prevent complications associated with too shallow intubation. An optimal endotracheal tube (ETT) placement should also ensure sufficient distance (2–5 cm) between the tip of the ETT and the carina.3 The increase in ETT tip-carina distance in adults with head and neck extension has been reported to range from a mean of 0.6 cm6,7 to a mean of 2.7 cm.8 This increase is attributed to lengthening of trachea and proximal migration of the ETT due to head and neck extension.9 Most ETTs for the adults have two black insertion guide marks at 2 and 4 cm above the cuff or one mark at 2–3 cm above the cuff.5 Alignment of the marks with the vocal cords helps to place the ETT at the correct depth.6 However, this technique relies on visualization of the vocal cords with a laryngoscope which is difficult in patients with large tongue, prominent teeth, a short neck. Besides, in cases with limited mouth opening where only nasotracheal route of intubation is possible, the depth markers cannot be observed. Although some studies have used fiberoptic bronchoscope (FOB) to make sure that the ETT cuff was 2–3 cm below the vocal cords,17,18 it was found difficult to identify the cuff and the vocal cords via FOB when the ETT was already in place, especially in flexometallic tubes and silicon Ring-Adair-Elwyn (RAE) tubes as this tube is opaque. Fiberoptic examination through the tracheal tube will indicate the position of the tip relative to the carina, but gives little information about the proximity of the cuff to the vocal cords.5 In patients with craniofacial anomalies or any abnormalities of the upper airway such as tumor and temporomandibular joint disorders, or post radiotherapy for head and neck cancers have potential difficulty with airway management and it is important in these cases to ensure appropriate positioning of the endotracheal tube. In various studies measurements were made with the head in neutral position. If the head position changes during surgery, the tube depth should be adjusted accordingly. In addition to routinely measuring ETT tip to carina distance, the mark at vocal cords can be visualized using FOB through opposite nostril, a safe distance between the vocal cords and the ETT cuff can potentially be guaranteed by this method. We hypothesize that FOB can be used to reliably estimate the distance between the upper edge of the ETT cuff and the vocal cords in adults so that the depth of the ETT can be adjusted accordingly after positioning the head and neck during surgery. |