| CTRI Number |
CTRI/2024/03/064561 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the duration taken for SpO2 to drop from 100% to 95% after giving Positive End-Expiratory Pressure during face mask ventilation with and without it during general anesthesia. |
|
Scientific Title of Study
|
Comparison of safe apnea time with and without Positive
End-Expiratory Pressure during face mask ventilation in adult patients undergoing general anesthesia. |
| 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 Deepak Raj G |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
7904760828 |
| Fax |
|
| Email |
g.deepakraj8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building, Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and Intensive Care, ground floor, main ot complex, VMMC and Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi |
| 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 Deepak Raj G |
VMMC and Safdarjung Hospital |
Safdarjung Hospital Campus, Ansari Nagar East, New Delhi, Delhi
New Delhi
DELHI |
7904760828
g.deepakraj8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
Administration of positive end exploratory pressure during face mask ventilation |
By administering positive end expiratory pressure we are trying to see whether the safe apnoea time can be increased or not |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age between 18-60 years belonging to ASA grade I-II undergoing elective surgery
under general anesthesia with Endotracheal Intubation (ETT) |
|
| ExclusionCriteria |
| Details |
1. SpO2 less than 97% at room air
2. Body Mass Index more than 25kg/m2
3. Anticipated difficult intubation/ventilation
4. Indwelling nasogastric tube
5. History of Obstructive sleep apnoea
6. History of any Respiratory illness
7. Pregnancy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the safe apnea time |
the safe apnoea time will be the duration from the moment the face mask ventilation is stopped to the moment the spo2 drops till 95% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare PaO2/FiO2 ratio |
ABG will be taken immediately after the 3 minutes of face mask ventilation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2024 |
| 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
|
Face Mask Ventilation is done immediately after the induction of general anesthesia, there are various techniques to do face mask ventilation and one of which is administration of positive end expiratory pressure during face mask ventilation. Here we are trying to compare the duration of safe apnea time after administration of positive end expiratory pressure and without it and determine which has more duration. This can help the anesthesiologists to follow a standard technique to counter any unanticipated cannot ventilate cannot intubate situation if at all it happens. The methodology will be, after explaining the subjects who are posted for elective surgery about the study and getting informed consent. The subjects are divided into 2 groups (group P - PEEP of 6cmH2O and group C - PEEP of 0cmH2O) using block randomization and allotted into 1 of the 2 groups. The patient will be taken to operation theatre and general anesthesia will be induced after which face mask ventilation will be done using the ventilator and according to their groups. After 3 minutes of face mask ventilation the timer will started to document the apnea time i.e., the duration taken for SpO2 to drop from 100% to 95%. We hypothesize that the duration of apnea will be longer in group P when compared to group C. We are also trying to see the difference in PaO2/FiO2 ratio between the 2 groups |