| CTRI Number |
CTRI/2023/03/050900 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of POST with cuffed endotracheal tube in men and women with standard tracheal tube and one size smaller in laproscopic surgeries… |
|
Scientific Title of Study
|
"Evaluation of post operative sore throat (POST) using standard
versus smaller sized cuffed endotracheal tubes in patients undergoing laparoscopic surgeries." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nupur Agarwal |
| Designation |
Junior resident |
| Affiliation |
Mahatma Gandhi medical college and hospital |
| Address |
Room no 5, type 4A godhavari girls hostel mahatma Gandhi medical college and hospital sitapura Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9589347931 |
| Fax |
|
| Email |
nupsy.nupur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHAYYAM |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Mahatma Gandhi medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care,mahatma Gandhi Medical College and Hospital,Sitapur, Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9468964148 |
| Fax |
|
| Email |
khayyammoin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYAMVADA GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
Mahatma Gandhi medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Mahatma Gandhi Medical College and Hospital, Sitapura Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9413418336 |
| Fax |
|
| Email |
drpriyamvada@hotmail.co.uk |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi Medical College |
| Address |
Department of Anesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura,Jaipur,Rajasthan |
| Type of Sponsor |
Private 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 Nupur Agarwal |
Mahatma Gandhi Hospital and College |
Departmet of Anaesthesia and Critical Care,Mahatma Gandhi Hospital,Sitapura,Jaipur,Rajasthan
Jaipur
RAJASTHAN |
9589347931
nupsy.nupur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe |
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 |
insertion of smaller size cuffed endotracheal tube |
insertion of smaller size cuffed endotracheal tube and observing the incidence of post operative sore throat until 24 hours after surgery |
| Intervention |
insertion of standard calculated size endotracheal tube |
insertion of standard calculated size endotracheal tube and observing the incidnece of post operative sore throat until 24 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient fullfillig criteria of american society of anaesthesiology (ASA) of class I/II
Patient aged 18-65 years of both sexes
Patient posted for laproscopic surgeries under general annaesthesia
Patient giving consent for the study |
|
| ExclusionCriteria |
| Details |
Sore throat AND hoarseness
Anticipated difficult airway
Upper respiratory infection more than 1 month
Moderate/severe obstructive pulmonary disease
Previous ARDS or lung resection
BMI>35kg
Surgeries in trendlenberg position
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of post operative sore throat |
until 24 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare intra operative ventilatory parameter like peak inspiratory pressure,plateau pressure,cuff pressure and end tidal co2. |
150 minutes |
| To compare the severity of post operative sore throat, if it occurs |
until 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
12/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/06/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
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 is quite common occurence following general anaesthesia after tracheal intubation and impairs post operative recovery.it is a minor complication but ensures about patient comforts and further complications.Factors such as tracheal tube size and cuff design have been showed to be an important causative factors.Routine tracheal intubation for elective surgical procedure can result in pathological changes,trauma and nerve damage which may also accounts for post operative symptoms.Sore throat following the use of laryngeal mask appears to be related to insertion of technique.High intracuff pressure is associated with nerve palsies due to neuropraxia and nerve compression.Careful insertion of both tracheal tube and laryngeal mask paramounts to prevention of airway trauma and post operative sore throat. The goal is to relieve post operative sore throat and hoarseness of voice with minimal complications.Smaller diameter tracheal tube may decreases the rate of post operative sore throat.The concern may be increase the resistance to airflow and mean airway pressure.These effects can be attenuated by lower tidal volume with positive end expiratory pressure.We hypothesized that smaller tracheal tube would reduce the rate of postoperative sore throat without significantly increase in pressure during mechanical ventilation with lower tidal volume. |