| CTRI Number |
CTRI/2024/11/076521 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing airway seal effectiveness with different supraglottic breathing devices when head is turned |
|
Scientific Title of Study
|
Comparison of oropharyngeal leak pressure at head
rotation with LMA Proseal™ and I-gel® |
| 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 Kirti Kshetrapal |
| Designation |
Professor |
| Affiliation |
Pt B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9215650615 |
| Fax |
|
| Email |
kamalkirti47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit |
| Designation |
Postgraduate student |
| Affiliation |
PT B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053433750 |
| Fax |
|
| Email |
mohitmehra1719@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit |
| Designation |
Postgraduate student |
| Affiliation |
PT B.D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8053433750 |
| Fax |
|
| Email |
mohitmehra1719@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT B.D Sharma, PGIMS Rohtak |
|
|
Primary Sponsor
|
| Name |
PT B.D Sharma, PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,PGIMS Rohtak,Haryana, 124001, India |
| 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 Mohit |
PT B.D Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care,PGIMS Rohtak
Rohtak
HARYANA |
8053433750
mohitmehra1719@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics, Pt. B.D Sharma PGIMS, Rohtak |
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 |
I-gel of size 4 will be inserted into oro-pharynx of Group I patients |
After induction, I-gel of size 4 will be inserted into oro-pharynx. Five minutes after placement of SAD, the outcomes will be evaluated at right head-rotated positions in the order of neutral/0°, 30°,60°rotation in supine position. |
| Intervention |
LMA Proseal of size 4 will be inserted into oro-pharynx of Group P patients |
After induction, LMA proseal of size 4 will be inserted into oro-pharynx. Proseal cuff will be inflated to achieve an intra-cuff pressure of 60cm H2O with head an neck in neutral position. Five minutes after placement of SAD, the outcomes will be evaluated at right head-rotated positions in the order of neutral/0°, 30°,60°rotation in supine position. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-70 years of either gender weighing 50-70 kg belonging to American Society of Anesthesiologists(ASA) physical status I and II, and MPG I&II scheduled for surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients who do not give consent, difficult airway, patient at
high risk of pulmonary aspiration, high risk of barotrauma,
inadequate fasting, cervical spine disorders or restricted range
of head movement, mouth opening less than 3cm, morbid Obesity (
BMI more than 30 kg per metre square ),patients with loose dentures, pregnancy,
edentulous, being considered unsuitable for supraglottic airway device insertion
by attending anaesthesiologists. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the difference in oropharyngeal leak pressure with head rotation using LMA Proseal
and i-gel. |
5 minutes after insertion of Supraglttic Airway device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Insertion time of Supraglottic airway device, ease and attempts of insertion of
Supraglottic airway device, Oropharyngeal leak pressure, ventilation score, fiberoptic
grading, peak inspiratory pressure & expiratory tidal
volume in different head and neck positions
, Complications |
5 minutes after insertion of Supraglttic Airway device till1 our after removal of Supraglottic Airway device |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/11/2024 |
| 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="0"
Months="6"
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
|
This prospective, single centre, parallel group randomized study will be conducted in Department of Anesthesiology and Critical Care Pt. B.D. Sharma PGIMS, Rohtak after obtaining approval from institutional Ethical Committee. |