| CTRI Number |
CTRI/2024/11/077164 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the usefulness of two types of masks used to provide breaths during general anaesthesia |
|
Scientific Title of Study
|
Comparing the feasibility of ventilation with Novel nasal PAP device with conventional facemask in patients receiving general anaesthesia |
| 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 Muralidharan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,Mangalagiri |
| Address |
Department of Anaesthesia,AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9994972589 |
| Fax |
|
| Email |
muralikayal123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Eeshwar MV |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences,Mangalagiri |
| Address |
Room No.1052,
Dept of Anaesthesia,
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9740122272 |
| Fax |
|
| Email |
dreeshwarmv@aiimsmangalagiri.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Muralidharan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,Mangalagiri |
| Address |
Department of Anaesthesia,AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9994972589 |
| Fax |
|
| Email |
muralikayal123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology
AIIMS Mangalagiri
Guntur District
Andhra Pradesh
Pin 522503 |
|
|
Primary Sponsor
|
| Name |
AIIMSMangalagiri |
| Address |
Department of Anaesthesia
AIIMS Mangalagiri
Guntur District
Andhra pradesh
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 |
| Dr Muralidharan |
AIIMS,Mangalagiri |
Department of Anaesthesia,AIIMS Mangalagiri Guntur ANDHRA PRADESH |
9994972589
muralikayal123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS,Mangalagiri,Institute Ethics Committee |
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 |
Conventional Facemask |
Conventional facemask will be used to ventilate patients initally as the standard of care for all patients for about a minute under general anaesthesia and the parameters will be recorded every 15 seconds. |
| Intervention |
Novel Nasal PAP device |
Novel nasal PAP device will be used to ventilate patients for about a minute under general anaesthesia and the parameters will be recorded every 15 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA I-III aged from 18 to 65 yrs are included in the study |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patients with anticipated difficult mask ventilation
Patients with unanticipated difficult mask ventilation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To measure delta Vt (difference between set tidal volume and delivered tidal volume) using both Super NO2VA and conventional face mask |
T0-Baseline(Post Induction)
T1-15 secs
T2-30 secs
T3-45 secs
T4-60 secs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Change in the peak airway pressure (Paw)
•Change in SpO2
•Measure EtCO2 values with both techniques
•Grade the EtCO2 trace
•Monitor the use of airway adjuncts
•Agreeability between Super NO2VATM and conventional face mask
|
T0-Baseline(Post Induction)
T1-15 secs
T2-30 secs
T3-45 secs
T4-60 secs |
|
|
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)
|
01/01/2025 |
| 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="0" Months="11" 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
|
Mask ventilation is pivotal during general anaesthesia (GA) especially at induction, serving as the primary means of ventilation before securing a definitive airway. It encompasses two critical aspects: ensuring an airtight seal between the mask and the patient’s face to prevent gas leakage and maintaining an unobstructed upper airway. Despite this, patients are prone to airway obstruction. Using the 2-hand technique of mask ventilation and / or use of airway adjuncts such as oropharyngeal or nasopharyngeal airway might help relieve this obstruction. Nasal mask ventilation directs inspired air through the nasal cavity, countering gravity’s influence on the soft palate and tongue, thereby maintaining upper airway patency. Consequently, direct nasal ventilation may offer improved ventilation efficacy and a more natural breathing pattern. Continuous positive airway pressure (CPAP), delivered via non-invasive ventilation masks not only prevent upper airway collapse but also are being used in the ICUs to ventilate patients and also pre-oxygenate before intubating the critically ill. Literature also suggests using the Rendell Becker Soucek mask and even paediatric facemasks can be used for nasal ventilation in children and edentulous patients but these do not provide positive airway pressure (PAP) and neither are specifically designed to give a perfect fit. Super NO2VATM is specifically designed for nasal ventilation and also has the advantage of providing positive pressure ventilation that would maintain patency of upper airway. This novel device has been introduced in the market for its use in obese patients with obstructive sleep apnoea who are posted for procedures under sedation. In this study, we are using this device for mask-ventilating patients at the start of general anaesthesia and trying to compare its effectiveness with that of the Conventional Facemask technique of ventilation
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