| CTRI Number |
CTRI/2020/04/024873 [Registered on: 27/04/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [preoxygention with supplemental oxygen] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Use of nasal cannula oxygen for pre operative oxygen delivery: A randomized crossover study. |
|
Scientific Title of Study
|
Use of nasal cannula oxygen as a preoxygenation adjunct: A randomized crossover study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Murphy Joel J |
| Designation |
Postgraduate |
| Affiliation |
KMC, Manipal |
| Address |
Department of anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal,
Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9486550754 |
| Fax |
|
| Email |
murphyjoel1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savan Kumar |
| Designation |
Assistant professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal,
Karnataka- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8105308865 |
| Fax |
|
| Email |
savankum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savan Kumar |
| Designation |
Assistant professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of anaesthesiology,
Kasturba Medical College,
Madhav Nagar,
Manipal,
Karnataka- 576104
Hassan
KARNATAKA
576104
India |
| Phone |
8105308865 |
| Fax |
|
| Email |
savankum@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Madhav nagar,
Karnataka,
Manipal- 576104 |
| Type of Sponsor |
Private 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 |
| Murphy Joel J |
kasturba medical college |
department of anaesthesiology,
madhava nagar,
Manipal,
Karnataka- 576104
Udupi
KARNATAKA |
9486550754
murphyjoel1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no diseases. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
oxygen |
nasal oxygen along with preoxygenation with different flows of oxygen through the nasal cannula. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
healthy volunteers |
|
| ExclusionCriteria |
| Details |
1. people with known respiratory or cardiac diseases
2. pregnant people
3. people with facial trauma or irregular facial anatomy
4.patients with exposure to bleomycin or amiodarone |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that nasal cannula will improve pre oxygenation by increasing end tidal oxygen concentration with either 3 minute tidal volume breaths or 8 vital capacity breaths over 1 minute. |
3 minutes for tidal volume preoxygenation and 1 minute for vital capacity pre oxygenation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comfort of the patient with different flows through nasal cannula will be assesed. |
during the trial. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2020 |
| Date of Study Completion (India) |
04/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim is to find out if nasal cannula when used as an adjunct to face mask
improves ETO2.
Primary
Objectives: 1. To assess the ETO2 with face mask with and without
nasal cannula while breathing Tidal volume ventilation with 100% oxygen for 3
minutes.
2. To assess the ETO2 with
face mask and nasal cannula while preoxygenating with100% oxygen for 8 vital
capacity breaths over 1 minute. 3.
To compare the ETO2 with face mask and nasal cannula with 3 minute
preoxygenation and 8 vital capacity breaths.
Secondary objective: to
assess the comfort of the patient with nasal cannula |