| CTRI Number |
CTRI/2025/08/092282 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Preoxygenation will remove the need for providing breaths by bag and mask after giving general anesthesia |
|
Scientific Title of Study
|
Preoxygenation obviates the need of bag and mask ventilation after induction of general anesthesia-A prospective, observational, case control, pragmatic trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Sankar Nath |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesia, Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09648935430 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Sankar Nath |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesia, Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09648935430 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Sankar Nath |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anesthesia, Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09648935430 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
|
Source of Monetary or Material Support
|
| It is an intra mural project supported by Dr Ram Manohar Lohia Institute of Medical Sciences Lucknow INDIA PIN 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Soumya Sankar Nath |
| Address |
Dr Ram Manohar Lohia Institute of Medical Sciences Vibhuti Khand Lucknow INDIA |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Samiksha Parashar |
Dr Ram Manohar Lohia Institute of Medical Sciences LucknowVibhuti Khand Lucknow INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soumya Sankar Nath |
Dr Ram Manohar Lohia Institute of Medical Sciences |
First floor ICU, Department of Anesthesia, Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand Lucknow INDIA PIN 226010
Lucknow
UTTAR PRADESH |
09648935430
soumynath2185@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Withold mask ventilation |
Patients of study group will not receive bag and mask ventilation after general anesthesia till intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adult patients (18-70 years), of both genders, of American Society of Anaesthesiologists functional class I or II, planned for elective surgery under GA with muscle relaxant, endotracheal intubation and controlled ventilation, AND in whom there exists need for intra-arterial cannulation.
|
|
| ExclusionCriteria |
| Details |
ASA functional class III and more, emergency surgeries, pregnancies, and lung related issues like chronic obstructive airway diseases, restrictive diseases, bronchial asthma, anticipated difficult airway, oropharyngeal or facial abnormalities making mask ventilation difficult and increased risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcomes that will be measured is the percentage of patients whose SpO2 drops below 95%.
|
At the end of period of apnea when the second sample of blood gas is collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. a. To compare the peripheral oxygen saturation (SpO2), partial pressure of carbon dioxide levels, and pH among patients who were ventilated with bag and mask and those who were not ventilated during the apnea period. |
One year |
| b. To measure the safe apnea period among patients who were not ventilated during the apnea period. |
One year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Pre-oxygenation meaning patient made to breathe pure oxygen prior to administration of general anesthesia (GA) is an time-honoured practice among anesthesiologists It aids in denitrogenation of the lungs and allows longer apnea time. After induction of GA including muscle relaxant for a variable period till adequate effect of muscle relaxant is established the patients are ventilated by bag and mask with pure oxygen During bag and mask ventilation there is the the potential risks of gastric insufflation (predisposes patients to aspiration and gastric injuries during laparoscopic surgeries) and hyperventilation (raises the intrathoracic pressure leading to reduced cardiac output and hypotension) We hypothesise that with adequate preoxygenation, there is no need of bag and mask ventilation of patients after induction of GA till endotracheal intubation. |