| CTRI Number |
CTRI/2024/05/068206 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the drop in oxygen concentration at the level of pharynx compared to oxygen concentration at the level of nostrils. |
|
Scientific Title of Study
|
Comparison of pharyngeal oxygen concentration and delivered oxygen concentration during preoxygenation with High Flow Nasal cannula |
| 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. Saveetha Priya M.G |
| Designation |
Junior Resident |
| Affiliation |
JIPMER , Puducherry |
| Address |
Department of Anaesthesiology and Critical Care
Old Block
Dhanvantari Nagar
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9176328226 |
| Fax |
|
| Email |
JR8013@jipmer.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudevan A |
| Designation |
Professor |
| Affiliation |
JIPMER , Puducherry |
| Address |
Department of Anaesthesiology and Critical Care
Old Block
Dhanvantari Nagar
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894444102 |
| Fax |
|
| Email |
jipmervasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Saveetha Priya M.G |
| Designation |
Junior Resident |
| Affiliation |
JIPMER , Puducherry |
| Address |
Department of Anaesthesiology and Critical Care
Old Block
Dhanvantari Nagar
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9176328226 |
| Fax |
|
| Email |
JR8013@jipmer.ac.in |
|
|
Source of Monetary or Material Support
|
| Intramural funding
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
intramural funding , JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantari Nagar
Puducherry 605006 |
| 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 |
| DrSAVEETHA PRIYA M G |
Jawarharlal Institute of Post Graduate Medical Education and Research |
Department of Anaesthesiology and Critical Care
Old Block
Dhanvantari Nagar
Puducherry 605006
Pondicherry
PONDICHERRY |
9176328226
JR8013@jipmer.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
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 |
NIL |
NIL |
| Intervention |
oxygenation |
Oxygen will be administered to the study group via High Flow Nasal cannula device starting from a flow rate of 10l to 60l each lasting for a period of one minute each |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-60 year
2.ASA Physical status class I & II
3.Patients undergoing oro-tracheal intubation under general anaesthesia
4.expected duration of surgery of more than one hour |
|
| ExclusionCriteria |
| Details |
1.Patients with existing respiratory illness
2.Pregnant patients
3.Patients with gross facial anomalies
4.Patients with any nasal or nasopharyngeal mass |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the highest pharyngeal FiO2 with delivered FiO2 . |
One hour before starting of general anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find association between set flow rate & change in FiO2 during HFNO preoxygenation. |
The flow rate will be increased at increments of 10L upto 60L, each flowrate given during a period of one minute. |
| To find association between nasal patency & change in FiO2 during HFNO preoxygenation. |
Will be done before the patient gets shifted inside the operation theatre at preoperative holding area. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 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
|
comparing pharyngeal oxygen concentration and delivered oxygen concentration during preoxygenation during High Flow Nasal cannula among patients posted for elective surgeries who undergo oro-tracheal intubation for general anaesthesia |