| CTRI Number |
CTRI/2025/05/086604 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of Preoxygenation which is done before intubation with face mask along with apnoeic oxygenation with nasal cannula versus face mask alone which is standard method in patients undergoing intubation in emergency: A randomized control trial. |
|
Scientific Title of Study
|
Comparison of efficacy of Preoxygenation standard face mask along with apnoeic oxygenation with nasal cannula versus face mask alone in patients undergoing intubation in emergency: A randomized control 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 |
Dr Parampreet singh |
| Designation |
junior resident |
| Affiliation |
AIIMS rishikesh |
| Address |
Room no. 521, building no 84, AIIMS RISHIKESH.
Village: Nagla jagir, Post office: Pabni kalan, City: jagadhri
Yamunanagar
HARYANA
135003
India |
| Phone |
8607944989 |
| Fax |
|
| Email |
parampreetsinghynr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Arora |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Room no. 4, Emergency department, Level - 1, AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8477987835 |
| Fax |
|
| Email |
poonam.em@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parampreet singh |
| Designation |
junior resident |
| Affiliation |
AIIMS rishikesh |
| Address |
Room no. 521, building no 84, AIIMS RISHIKESH.
Village: Nagla jagir, Post office: Pabni kalan, City: jagadhri
Yamunanagar
HARYANA
135003
India |
| Phone |
8607944989 |
| Fax |
|
| Email |
parampreetsinghynr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All indian institute of medical sciences, Rishikesh, Uttarakhand, 249203 |
|
|
Primary Sponsor
|
| Name |
no sponser |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Parampreet singh |
AIIMS RISHIKESH |
Red area, Emergency department
Dehradun
UTTARANCHAL |
8607944989
parampreetsinghynr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Rishikesh |
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 |
pre oxygenation with bag and mask alone |
pre oxygenation will be done for 3 min with bag and mask alone |
| Intervention |
pre oxygenation with bag and mask along with nasal cannula |
pre oxygenation for 3 minutes will be done with bag and mask along with apnoeic oxygenation ( oxygen flow of 15 L/min) will continue while laryngoscopy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes patient coming to emergency department age more than 18, requiring intubation and willing to take part in trial. |
|
| ExclusionCriteria |
| Details |
1. Patient in cardiac arrest
2. Pregnant and breast feeding
3. Already receiving positive pressure ventilation
4. Patient requiring delayed sequence intubation
5. Patient requiring video or fibre optic intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| lowest oxygen saturation during the interval between induction of anaesthesia till 2 minutes after tracheal intubation |
the interval between induction of anaesthesia before intubation till 2 minutes after the procedure of intubation is completed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hypoxemia during intubation i.e. oxygen saturation of less than 90 %. |
Interval from induction of anaesthesia till 2 minutes after tracheal intubation |
| Severe hypoxemia during intubation i.e. oxygen saturation of less than 80%. |
Interval from induction of anaesthesia till 2 minutes after tracheal intubation. |
| Change in oxygen saturation |
Recorded before pre oxygenation & after 3 minutes of pre oxygenation. |
| hypoxemia post intubation i.e. oxygen saturation of less than 90%. |
During the interval from 2 to 15 minutes after tracheal intubation |
|
|
Target Sample Size
|
Total Sample Size="618"
Sample Size from India="618"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/05/2025 |
| 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="1"
Months="0"
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
|
The pre oxygenation with standard face mask along with apnoeic oxygenation using nasal cannula can better prevent oxygen desaturation during procedure of intubation as compared to pre oxygenation with face mask alone. |