| CTRI Number |
CTRI/2024/03/064259 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the endotracheal tube cuff pressures for patients under general anesthesia with endotracheal tube |
|
Scientific Title of Study
|
Comparison of endotracheal cuff pressures inflated using two techniques - Minimal occlusive volume (MOV) and Pressure Volume Loop closure (PVL-C) used as a guide to provide adequate seal of airway. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarti Kulkarni |
| Designation |
Additional Professor |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
Department of Anaesthesiology, 1st floor, Old Hospital building, KEM hospital, Acharya Dhonde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820452868 |
| Fax |
|
| Email |
aartikulkarni@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Soni |
| Designation |
Junior Resident |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
Department of Anaesthesia, 1st floor, Opposite INR 53, Old Hospital Building, KEM hospital, Acharya Dhonde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167649061 |
| Fax |
|
| Email |
sonishrut@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Soni |
| Designation |
Junior Resident |
| Affiliation |
Seth GS Medical College and KEM hospital |
| Address |
Department of Anaesthesia, 1st floor, Opposite INR 53, Old Hospital Building, KEM hospital, Acharya Dhonde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167649061 |
| Fax |
|
| Email |
sonishrut@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, GS Medical College and KEM hospital, Acharya Dhonde Marg, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM hospital |
| Address |
Seth GS Medical College and KEM hospital, Acharya Dhonde Marg, Parel, Mumbai 400012 |
| 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 Shruti Soni |
Seth GS Medical College and KEM hospital |
Department of Anaesthesiology, Seth GS Medical College and KEM hospital, Acharya Dhonde Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9167649061
sonishrut@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) II, Seth GS Medical College and KEM hospital |
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 |
MOV technique |
In the MOV technique, cuff is slowly inflated with 2ml air followed by 0.5 ml increments until the air leakage sound disappeared. The audible air leakage sound will be identified with a stethoscope at the neck of the patient. When the air leakage sound disappears, the cuff pressure and the volume of air injected into the cuff will be recorded |
| Comparator Agent |
PVL-C technique |
In the PVL-C technique, the cuff will be slowly inflated with 2ml air followed by 0.5 ml increments. When the Pressure Volume Loop curve is completed ie when the expiratory limb reaches zero volume and meets the starting point of inspiratory limb, inflation of cuff will be ceased and the cuff pressure and the volume of air injected into the cuff will be recorded |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients planned for elective surgeries under general anaesthesia with cuffed endotracheal tube in supine position |
|
| ExclusionCriteria |
| Details |
Patients with anticipated difficult intubation or History of difficult intubation
Known anatomical laryngeal abnormalities
Past history of tracheostomy
BMI more than 30 kg/m2
Pregnant females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and compare cuff pressures obtained by MOV and PVL techniques of cuff inflation. |
immediately post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record
The volume of air introduced in the cuff
The incidence of side effects like sore throat and hoarseness associated with different cuff pressures.
|
immediately Post intubation
Upto 24 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The endotracheal tube (ETT) with a cuff is used
in mechanically ventilated patients. ETT cuff sealing is necÂessary to ensure
mechanical ventilation with adequate tidÂal volume, to prevent accidental
extubation and to prevent aspiration of orogastric contents into airway. A
higher cuff pressure can result in complete airway sealing without air leakage;
however, increased cuff pressure can contribute to tracheal injuries, decreased
tracheal capillary perfusion Therefore, it is important to mainÂtain proper
cuff pressure that guarantees airway sealing without overinflating the ETT
cuff. The most routine way of inflating cuff is injection of fixed amount of
air with a syringe. It is an easy, simple and inexpensive method but often
leads to cuff distension and over pressure. Therefore, it is important we use a
method which provides adequate occlusion and safest pressure. This study aimed to evaluate the difference in
cuff pressure between the techniques used to inflate the ETT cuff. |