| CTRI Number |
CTRI/2024/07/071417 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| 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
|
oxygen is provided by two different devices, one group will be oxygen provided by mask ventilation and one group will oxygen provided by HFNC device. and compare the saturation level
|
|
Scientific Title of Study
|
Comparison of apnea time using Intermittent mask ventilation vs High flow nasal cannula in upper endoscopic procedure A Prospective Randomized Study |
| 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 Arpit Patel |
| Designation |
Resident Doctor |
| Affiliation |
Government medical college , Bhavnagar , |
| Address |
Department of anaesthesiology Government Medical college, Bhavnagar
Sir T hospital, kala nala road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428768438 |
| Fax |
|
| Email |
abpatel3504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lopa Trivedi |
| Designation |
Associate and head of the department of anaesthesiology Government medical college , bhavnagar |
| Affiliation |
Government medical college , Bhavnagar , |
| Address |
Government medical college , Bhavnagar
Sir T hospital, Bhavnagar, kalanala road , Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428009958 |
| Fax |
|
| Email |
trivedi_lopa@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lopa Trivedi |
| Designation |
Associate and head of the department of anaesthesiology Government medical college , bhavnagar |
| Affiliation |
Government medical college , Bhavnagar , |
| Address |
Government medical college , Bhavnagar
Sir T hospital, Bhavnagar, Kala nala road , Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9428009958 |
| Fax |
|
| Email |
trivedi_lopa@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology, Sir T hospital, Bhavnagar, Gujrat , 364001 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Government Medical college, Sir T Hospital, Bhavnagar, 364001, gujrat |
| 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 Arpit Patel |
Sir T Hospital , Bhavnagar |
Government Medical college, Sir T Hospital, Bhavnagar, 364001, gujrat
Bhavnagar
GUJARAT |
9428768438
abpatel3504@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
high flow nasal cannula |
oxygen is provided at high flow rate through nasal cannula [70 lit/min] which ensures accurate delivery of high flow of oxygen and titration of fio2 up to 100%,through out the operation time till apnea time [ 90% prolongation of safe apnea time, effective humidification of delivered gas, and precision of the inspired gas. HFNC device does not occupy the surgical field , which allow the surgeon to obtain a good surgical field of vision during the operation.
Increased apnea time without desaturation enabling surgery to be carried out in good condition and without interference of mask ventilation. there will be 10 to 15 minutes monitoring of vitals .
|
| Comparator Agent |
intermittent mask ventilation |
If HFNC is used, oxygen is provided at high flow rate through nasal cannula [70 lit/min] which ensures accurate delivery of high flow of oxygen and titration of fio2 up to 100%, prolongation of safe apnea time, effective humidification of delivered gas, and precision of the inspired gas. HFNC device does not occupy the surgical field , which allow the surgeon to obtain a good surgical field of vision during the operation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent
Age between 18 to 70 years
BMI less than 25 kg/m2
|
|
| ExclusionCriteria |
| Details |
Nasal Airway Obstruction
Tracheostomy in situ
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the apnea time in Intermittent mask ventilation and High flow nasal cannula in both the groups.
|
12 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
EtCO2
MAP
Pulse rate
Heart rate
Surgeon satisfaction score
|
12 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
•Aim : To compare apnea time using intermittent mask ventilation and HFNC in upper endoscopic procedure.
•Objective ØPRIMARY OBJECTIVE: • To compare the apnea time in Intermittent mask ventilation and High flow nasal cannula in both the groups. ØSECONDARY OBJECTIVE To compare the following parameter in both groups. •EtCO2 •MAP •Pulse rate •Heart rate •Surgeon satisfaction score |