| CTRI Number |
CTRI/2023/06/054077 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
three methods of endotracheal tube cuff inflation are compared in adult patients under general anaesthesia with endotracheal intubation |
|
Scientific Title of Study
|
comparison of three endotracheal tube cuff inflation techniques to obtain recommended endotracheal tube cuff pressure in adult patients undergoing general anaesthesia with endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parkhi Bharti |
| Designation |
post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung hospital
South West
DELHI
110019
India |
| Phone |
8745004603 |
| Fax |
|
| Email |
bhartijune14parkhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Department of Anaesthesia and Critical Care
South West
DELHI
110019
India |
| Phone |
8745004603 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parkhi Bharti |
| Designation |
post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Department of Anaesthesia and Safdarjung Hospital
South West
DELHI
110019
India |
| Phone |
8745004603 |
| Fax |
|
| Email |
bhartijune14parkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital; |
|
|
Primary Sponsor
|
| Name |
Dr Suman Saini |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Department of Anaesthesia and Critical Care |
| Type of Sponsor |
Government medical college |
|
|
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 parkhi bharti |
vardhman mahavir medical college and safdarjung hospital |
Department of anaesthesia and critical care, Vardhman Mahavir medical college and Safdarjung hospital
South West
DELHI |
8745004603
bhartijune14parkhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
endotracheal tube cuff inflation |
endotracheal tube cuff will be inflated using three different techniques |
| Comparator Agent |
loss of resistance syringe used in epidural set |
the endotracheal tube cuff is inflated using loss of resistance syringe and the cuff pressure is measured to check if it can achieve the recommended pressure range |
| Comparator Agent |
manual palpation method |
the endotracheal tube cuff will be inflated using a regular 10 ml syringe and pilot balloon palpated to decide if the pressure is satisfactory and the cuff pressure will be measured to check if it can achieve the recommended pressure range |
| Comparator Agent |
syringe with pressure device |
use of syringe with pressure device to inflate the endotracheal tube cuff and the pressure is measured to check if it can achieve the recommended pressure range |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
under American society of physical status (ASA) grade 1-3 who are undergoing elective surgical procedure lasting upto 3 hours |
|
| ExclusionCriteria |
| Details |
surgical procedure duration greater than 3 hours.
patients with anticipated difficult airway.
patients with preoperative cough or upper airway diseases.
patients with known or anticipated risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the accuracy of three different techniques using pressure value in the endotracheal tube cuff immediately following inflation in adult patients undergoing general anaesthesia with endotracheal intubation |
immediately following inflation of tube cuff |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percentage of patients having cuff pressures within the optimal or recommended range 20-25 cm of water. |
24 hour |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
endotracheal intubation is routinely performed for patients undergoing general anaesthesia.it is crucial to maintain appropriate cuff pressure to avoid cuff related serious adverse events. under inflation may lead to gastric distension, aspiration of oropharyngeal secretions, leakage of anaesthetic gases and thereby environmental pollution. overinflation may lead to compromised local tissue blood flow, necrosis and damage to surrounding anatomical structures. recommended range for cuff pressure is 20-25cm of water. we will be using three different methods of endotracheal tube cuff inflation in adult patients undergoing general anaesthesia with endotracheal intubation and check to see which is the best in achieving the cuff pressures in the recommended range. after a written and informed consent the methods used are pilot balloon palpation following cuff inflation by a regular 10ml syringe, use of loss of resistance syringe used in epidural sets and a syringe device with pressure sensor. we hypothesise that most appropriate cuff pressures are achieved by syringe device with pressure sensor. study design is a prospective interventional randomised controlled study with a sample size of 150 comprising 50 patients per group. |