| CTRI Number |
CTRI/2020/07/026314 [Registered on: 02/07/2020] Trial Registered Prospectively |
| Last Modified On: |
01/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [pre-operative oxygen therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare before oxygenation of fast induction in pre-decided surgery with facemask and high flow nasal cannula. |
|
Scientific Title of Study
|
Comparison of Pre-oxygenation with High Flow Nasal Cannula and Facemask in patients undergoing Rapid sequence induction of Anaesthesia for Elective surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Kumar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia,PGIMER Building,Dr Ram Manohar Lohia Hospital,Baba khadak singh road,New delhi
Central
DELHI
110001
India |
| Phone |
9650054017 |
| Fax |
|
| Email |
santosh.santy56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Banerjee |
| Designation |
Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia,PGIMER Building,Dr Ram Manohar Lohia Hospital,Baba khadak singh road,New Delhi
Central
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Kumar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia,PGIMER Building,Dr Ram Manohar Lohia Hospital,Baba khadak singh road,New Delhi
Central
DELHI
110001
India |
| Phone |
9650054017 |
| Fax |
|
| Email |
santosh.santy56@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital,Baba kharak singh Road,near Gurudwara Bangla sahib,Ram Manohar Lohia Hospital,New Delhi,Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS and Dr RML Hospital,Baba kharak singh Road,near Gurudwara Bangla Sahib,Ram Manohar Lohia Hospital,New Delhi,Delhi 110001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Santosh Kumar |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
Department of Anaesthesia,PGIMER Building, Dr Ram Manohar Lohia Hospital, Baba khadak singh road, New delhi
Central
DELHI |
9650054017
santosh.santy56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,ABVIMS and Dr RML Hospital,New delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Face Mask |
Patient will be Pre-oxygenated with face mask using circle system @ 12 lit/min with oxygen. |
| Intervention |
High Flow Nasal Cannula |
Patients is pre-oxygenated with High Flow Nasal Cannula for 4 minutes with flow rate 30lit/min and increased upto 60 lit/min over one minute and maintained. Patient is instructed to keep mouth close and take slow deep breathing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I,II. |
|
| ExclusionCriteria |
| Details |
Pregnancy.
Upper airway pathology.
Cervical Spine fracture.
Facial fracture and Maxillofacial abnormality.
Inter incisor distance <3cm.
Patient with Past history of Difficult intubation. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxygen saturation at Baseline and its changes during intubation procedures. |
oxygen saturation at Baseline and its changes at 3 end points.
T1- After pre-oxygenation(4 minutes).
T2- At the time of laryngoscopy(5 minutes).
T3-One minute after intubation(6 minutes). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
End Tidal oxygen concentration.
Apnoea time measurement. |
Eto2 at 4 minutes and Apnoea time measurements after 4 minutes until Endotracheal tube placed. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/07/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study ,we compare pre-oxygenation with high flow nasal cannula and facemask in patients undergoing rapid sequence induction of general anaesthesia in elective surgery. and we also compare end tidal oxygen concentration as measure of effective pre-oxygentaion with high flow nasal cannula and facemask in patients undergoing rapid sequence induction of general anaesthesia in elective surgery. |