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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  
None 
 
Primary Sponsor  
Name  Seema 
Address  Department of Anesthesia , AIIMS Bhopal 
Type of Sponsor  Other [Self] 
 
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 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.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.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.

 
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