| CTRI Number |
CTRI/2025/03/083130 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing whether the use of a special tube inserted during general anaesthesia with that of regular tubes in reducing sore throat in the general public |
|
Scientific Title of Study
|
To compare the efficacy of novel adaptive cuff Endo tracheal tube with that of polyvinyl Endo tracheal tubes in reducing postoperative sore throat |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
09740122272 |
| Fax |
|
| Email |
eeshwar.kmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
ANDHRA PRADESH
522503
India |
| Phone |
09740122272 |
| Fax |
|
| Email |
eeshwar.kmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eeshwar M V |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
No. 1051
Dept. of anaesthesiology
ANDHRA PRADESH
522503
India |
| Phone |
09740122272 |
| Fax |
|
| Email |
eeshwar.kmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUE OF MEDICAL SCIENCE MANGALAGIRI, Guntur, Andhra Pradesh, India
Pincode 522503 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE MANGALAGIRI |
| Address |
MANGALAGIRI
GUNTUR DISTRICT
ANDHRA PRADESH
INDIA
PINCODE 522503
|
| 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 |
| Eeshwar M V |
All India Institute of Medical Science Mangalagiri |
No. 1051
Dept. of anaesthesiology
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH |
09740122272
eeshwar.kmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Novel adaptive cuff endotracheal tube |
Novel adaptive cuff tubes have a special feature of expanding during positive pressure ventilation creating a seal and deflate during exhalation thus preventing continuous pressure on tracheal mucosa |
| Comparator Agent |
polyvinyl chloride endotracheal tubes |
polyvinyl endotracheal tubes are routinely used to ventilate patients under general anaesthesia. It has been found to be associated with post operative sore throat. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status of I to III
Mallampati Grade of I and II
Scheduled for elective surgery under general anaesthesia requiring placement of endotracheal tube
Duration of surgery between 60 to 240 minutes
|
|
| ExclusionCriteria |
| Details |
History of recent upper respiratory tract infection or sore throat
Anticipated difficult airway or those who require more than one attempt at endotracheal intubation
Traumatic intubation or blood stained ETT
Inability to ventilate (leaks) with the adaptive cuff tubes
Preoperative use of analgesic medications (Paracetamol/NSAIDs/Opioids) within 24 hours of surgery
H/O lung diseases and smoking
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the incidence of sore throat in patients whom novel tube is being used |
To assess for sore throat after the surgery
Immediately at the end of anaesthesia
At 2 hours postoperatively
At 6 hours postoperatively
At 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check for cuff pressures intraoperatively
To look for post operative nausea and vomitting |
T1 - 15 minutes into surgery
T2 - 30 minutes into surgery
T3 - 45 minutes into surgery
T4 - 60 minutes into surgery
T5 - 75 minutes into surgery
T6 - 90 minutes into surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/04/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Post operative sore throat with the use of endotracheal tubes is reported to have an incidence of up to 62%. Some of the known risk factors include, female sex, young age, smokers, preexisting lung disease, blood-stained endotracheal tubes, use of double lumen tubes, intubation without neuromuscular blockade and higher cuff pressure. There were many limitations noted in the studies conducted on POST as per the various systematic reviews. There are many techniques described to reduce the incidence of POST few of which include application of lignocaine gel on the cuff, injection of intravenous lignocaine in the cuff, application of steroid cream on the cuff, use of NMDA receptor antagonists like magnesium sulphate and ketamine both IV and gargling solutions etc. Few studies have proposed that the lignocaine spray or gel might themselves cause POST due to the presence of irritant additives in them. Despite the use of all the above, still the incidence and the patient discomfort remains high.The novel adaptive cuff technology endotracheal tube were introduced recently that prevent exertion of continuous pressure on the tracheal mucosa throughout the surgery. We aim to compare the novel adaptive ETT with the routine poly vinyl chloride endotracheal tube in reducing the incidence and severity of post operative sore throat. |