| CTRI Number |
CTRI/2024/06/069058 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of different levels of positive pressure at end expiration during pressure control face mask ventilation on air entry into stomach during planned surgery |
|
Scientific Title of Study
|
Effect of different levels of Positive end expiratory pressure on gastric insufflation during pressure- controlled face mask ventilation in patients undergoing elective surgery under general anaesthesia : A randomized control study |
| 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 Anjali Rawat |
| Designation |
Post Graduate Resident |
| Affiliation |
Delhi University |
| Address |
Department of Anaesthesiology and Intensive care,Maulana Azad Medical College and associated Lok Nayak Hospital,
New delhi
India
Central
DELHI
110002
India |
| Phone |
7428755230 |
| Fax |
|
| Email |
rawatdranjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munisha Agarwal |
| Designation |
Director professor and Head of Department |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesiology, Maulana Azad Medical college and and associated Lok Nayak hospital,2 Bahadur Shah Zafar Marg
Central Delhi
New delhi India
Central
DELHI
110002
India |
| Phone |
9968604219 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Rawat |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Anaesthesiology Maulana Azad Medical college
and associated Lok nayak hopital
2 Bahadur Shah Zafar Marg
cental delhi
New delhi
India
Central
DELHI
110002
India |
| Phone |
7428755230 |
| Fax |
|
| Email |
rawatdranjali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical College
and associated Lok Nayak Hospital,
2 Bahadur Shah Zafar Marg,
Central Delhi
New Delhi
India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Maulana Azad Medical College and associated with Lok Nayak Hospital,
2 Bahadur Shah Zafar Marg
Central Delhi
New Delhi India-110002 |
| 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 Anjali |
Lok Nayak Hopital |
Operation theatre block,
Maulana Azad medical College and associated Lok Nayak Hospital,
2 Bahadur Shah Zafar Marg
New delhi
Central Delhi
India-110002
Central
DELHI |
9910476419
rawatdranjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PEEP0 |
Preoxygenation will be done without CPAP.
After induction patient shifted to pressure control face mask ventilation, Pi(10 mm Hg) will be increased every 2 minutes till gastric insufflation is detected. |
| Intervention |
PEEP10 |
Preoxygenation will be done with CPAP of 10 mm hg. After induction patient will be shifted to pressure control face mask ventilation, Pi(15 mm Hg) will be increased every 2 minutes (by 5 mm hg)till gastric insufflation is detected. |
| Comparator Agent |
PEEP5 |
Preoxygenation will be done with CPAP of 5 mm hg. After induction patient will be shifted to pressure control face mask ventilation, Pi(10 mm Hg) will be increased every 2 minutes (by 5 mm hg)till gastric insufflation is detected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1&2 |
|
| ExclusionCriteria |
| Details |
Anticipated difficult mask ventilation included but not limited to (MMP more than 3,Beard,Edentulous)
Obesity (BMI more than 30)
Patients with severe respiratory disease (COPD,Asthma etc )
Patients with known history of gastrointestinal disease, gastroesophageal reflux disease
Pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of real time ultrasonographic gastric insufflation with different levels of PEEP during Pressure control face mask ventilation |
After every 2 minutes of pressure control face mask ventilation (corresponding with increae in Pi) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of real time gastric insufflation on auscultation with different levels of PEEP on Pressure control face mask ventilation |
After every 2 minutes of pressure control face mask ventilation(corresponding to increase in inspiratory pressure (Pi)) |
| Cross sectional area & volume of gastric antrum with different levels of PEEP during pressure control face mask ventilation |
1.Baseline
2.After every 2 minutes of pressure control face mask ventilation(corresponding to increase in inspiratory pressure (Pi)) |
| Adequacy of ventilation as assessed by expired tidal volume & end tidal CO2 |
1.Baseline
2.After every 2 minutes of pressure control face mask ventilation(corresponding to increase in inspiratory pressure (Pi)) |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/06/2024 |
| 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="1"
Months="0"
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
|
Gastric insufflation during face mask ventilation may lead to increased intra abdominal pressure which may further cause pulmonary aspiration. CPAP during preoxygenation, followed by pressure controlled face mask ventilation with PEEP may benefit in reducing the above-mentioned risk. |