| CTRI Number |
CTRI/2024/12/078699 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two methods of sealing the tube in windpipe during course of anaesthesia in patients undergoing major cancer surgeries |
|
Scientific Title of Study
|
Comparing Conventional Endotracheal Cuff Inflation to Commercially Available Syringe Device: A Randomised Open Label Study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4578_Protocol Version 1.0 dated 19.08.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Chatterjee |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial HospitaL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322243936 |
| Fax |
|
| Email |
aparnasanjay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Chatterjee |
| Designation |
Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial HospitaL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322243936 |
| Fax |
|
| Email |
aparnasanjay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharanya M |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial HospitaL
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9740663549 |
| Fax |
|
| Email |
smsharanyamemana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, OT complex, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aparna Chatterjee |
Tata Memorial Hospital |
Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9322243936
aparnasanjay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
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 |
| Comparator Agent |
Conventional method of cuff inflation
|
Tn Comparator group, the endotracheal cuff will be inflated using a regular syringe with air until no palpable leak is detected while the patient is manually ventilated. |
| Intervention |
Novel Cuffsure device Endotracheal cuff inflation |
Intervention group involves usage of specialised inflation syringe (Cuffsure device), in which endotracheal cuff inflation will proceed until the pressure colour belt indicator displays a safe pressure range, indicated by the green mark corresponding to pressures of 20-30 cm of H20 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age
2. Patients posted for elective onco surgeries
3. Procedures requiring orotracheal intubation using single lumen endotracheal tube in OR |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Patients requiring nasotracheal intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of endotracheal intracuff pressures as inflated using conventional technique vs use of commercially available cuff inflation syringe. |
Immediately after insertion of endotracheal tube |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of overinflation & underinflation of the endotracheal cuff using the conventional method vs commercially available cuff inflation syringe |
1 minute after the pilot balloon is connected to the pressure transducer at the beginning |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction and background: Endotracheal intubation constitutes a routine part in providing general anaesthesia in OR and care of critically ill patients in ICU .A critical function of the endotracheal tube cuff is to seal the airway, thus preventing aspiration of pharyngeal contents into the trachea and to ensure that there are no leaks past the cuff during positive pressure ventilation. Different cuffs exist, high-volume low-pressure cuffs are the most used ones. High pressures exerted by cuff on tracheal mucosa can lead to reduction in blood flow to tracheal wall. Cuff pressure should be sufficient to prevent aspiration at the same time without compromising the tracheal blood flow. ETT cuff pressure between 20 and 30 cmH2O is considered to be the standard (safe) ETT cuff pressure range. Over inflation of cuff is associated with ischemia of tracheal wall mucosa, mucosal irritation, post operative sore throat, acquired laryngeal stenosis etc. Under inflation of cuff is associated with increases the risk of micro-aspirations and the passage of gastric contents and contaminated secretions of the oral cavity into the trachea; this potentially causing aspiration pneumonitis, accidental extubation and self extubation. Various methods of cuff inflation are present, stethoscope guided, palpation guided and audible leak guided method. Current practice widely followed at our institute is palpation guided technique. There are several commercial syringe devices available, designed for ETT cuff inflation with pressure values shown on the syringe device. The Cuffsure â„¢ syringe is a cuff inflation device, with a colour belt indicator showing safe cuff pressure range. The syringe is FDA approved for use in humans.
Rationale of the study: Numerous studies comparing different techniques for cuff inflation report a high incidence of cuff pressure out of range in a great proportion. Developing an objective way to inflate endotracheal cuff that is reasonable, simple, and accurate would be helpful. Further research examining objective methods is warranted. |