| CTRI Number |
CTRI/2024/06/068309 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Proseal Laryngeal Mask Airway Placement
Videolaryngoscope Guided Versus Classic Technique |
|
Scientific Title of Study
|
A Prospective Randomized Study ProSeal
Laryngeal Mask Airway Placement
Videolaryngoscpe-Guided Versus Classic Digital Technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harnoor Singh |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Student MMIMSR |
| Address |
Department Of Anaesthesia, MMIMSR, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8288846243 |
| Fax |
|
| Email |
harnoor996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babita Ramdev |
| Designation |
Professor |
| Affiliation |
MMIMSR |
| Address |
Department Of Anaesthesia, MMIMSR, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7888554917 |
| Fax |
|
| Email |
babitaramdev30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babita Ramdev |
| Designation |
Professor |
| Affiliation |
MMIMSR |
| Address |
Department Of Anaesthesia, MMIMSR, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7888554917 |
| Fax |
|
| Email |
babitaramdev30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, MMIMSR |
|
|
Primary Sponsor
|
| Name |
Harnoor Singh |
| Address |
Department Of Anaesthesia, MMIMSR, Mullana, Ambala |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Junior Resident |
MMIMSR |
OT Complex 2nd floor, Department Of Anaesthesia
Ambala
HARYANA |
8288846243
harnoor996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MMIMSR, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
ProSeal Laryngeal Mask Airway Placement |
ProSeal Laryngeal Mask Airway Placement Videolaryngoscope-Guided Versus Classic Digital Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with physical status ASA grade I or II.
2.All patients giving written informed consent.
3.Patients undergoing lower abdominal elective surgery under general anaesthesia.
4.Patients belonging to age group of 18 to 65 years
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal for the procedure.
2. Patient with anaemia.
3. ASA grade 3 and 4
4. Patient with significant coagulopathies.
5. Patient with known or suspected pregnancy.
6. Patient with renal or liver disease.
7. Non fasting patients.
8. Patients on antipsychotic medication.
9. Patients with increased risk of aspiration.
10. Patients with BMI more than 35 kg per square meter
11. Patients with difficult airway.
12. Patients having cervical spine diseases
13. Patients with pre-existing sore throat or hoarseness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of attempts, insertion time, leak volume, fibreoptic score, peak inspiratory pressure, to insert ProSeal LMA with videolaryngoscope D blade versus classic digital technique. |
Number of attempts to insert ProSeal LMA -3 attempts
Insertion time of ProSeal LMA-3minutes
Leak volume at 15 minutes
Fibre optic score at 3 minutes
Peak inspiratory pressure at 15 minutes
Oropharyngeal leak at 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the hemodynamic changes HR, SBP, DBP, MAP, SpO2 at various time intervals in both study groups.
2. To compare the complications and adverse effects of both the insertion techniques.
|
1- Hemodynamic changes observation
T0 -Baseline/Before induction
T1-Immediately after induction
T2-1 minute after insertion
T3- 3 minute after insertion
T4- 5 minutes after insertion
T5- 10 minutes after insertion
2-post extubation complications:
Blood stains on ProSeal LMA or videolaryngoscope
Sore throat
Hoarseness
Dysphagia
Cough
Vomiting
Bronchospasm
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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="1"
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
|
The Purpose Of This Randomised Prospective Clinical Trial Is To Evaluate The Effectiveness Of Two Different Insertion Techniques Of ProSeal LMA That Is Videolaryngoscope Guided Insertion Versus Classic Digital Insertion Technique |