| CTRI Number |
CTRI/2020/07/026482 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
04/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Oxygen therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing oxygenation between two techniques in patients, after extubation from general anaesthesia
1.High flow nasal cannula 2.venturi mask |
|
Scientific Title of Study
|
Comparison of oxygenation with high flow nasal cannula and venturi mask after extubation in adult patients undergoing general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay N |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology,
ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
9742297161 |
| Fax |
|
| Email |
drvijayn@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kumar Nagpal |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology,
ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay N |
| Designation |
PG Resident |
| Affiliation |
ABVIMS and Dr. RML Hospital |
| Address |
Department of Anaesthesiology,
ABVIMS and Dr. RML Hospital.
New Delhi
DELHI
110001
India |
| Phone |
9742297161 |
| Fax |
|
| Email |
drvijayn@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. RML Hospital |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi, India-110001 |
| 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 Vijay N |
ABVIMS and Dr RML Hospital |
3rd floor, Department of anaesthesia, PGIMER building
New Delhi
DELHI |
9742297161
drvijayn@yahoo.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: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Flow Nasal Cannula |
Patients will be kept supine with 20 degree propped up position. Oxygen will be delivered via High Flow Nasal Cannula at a rate of 15 L/min, temperature 37° c and FiO2 set at 60 %. |
| Comparator Agent |
Venturi mask |
Patients will be kept supine with 20 degree propped up position. Oxygen will be delivered via venturi oxygen mask (green colour) at a rate of 15 L/min with FioO2 set at 60 %. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 patients posted for elective surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with acute or chronic respiratory diseases.
2. Presence of neuromuscular disease.
3. Pregnancy.
4. BMI > 30 kg/m2.
5. Facio-maxillary abnormalities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxygenation by arterial blood gas analysis(pH, PaO2, PaCO2, P50, Haemoglobin saturation and PaO2/FiO2 ratio). |
0 min, 15 mins, 30 mins and 1, 2, 3 and 4 hours post extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (respiratory rate, heart rate, mean arterial pressure and SpO2). |
0 min, 15 mins, 30 mins and 1, 2, 3 and 4 hours post extubation. |
|
|
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)
|
01/08/2020 |
| 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="1"
Months="0"
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
|
This Randomized, Comparative study between High flow nasal cannula and venturi mask in patients extubated from general anaesthesia will be conducted in the Department of Anaesthesiology, ABVIMS and Dr RML hospital, New Delhi-110001.The study will include 60 patients (30 in each group) undergoing elective surgeries under general anaesthesia. The primary outcome of this study is to measure oxygenation by doing arterial blood gas analysis at serial time intervals. The secondary outcome will be hemodynamic changes seen at the same time intervals. |