| CTRI Number |
CTRI/2020/12/030029 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| 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
|
Effect Of Venturi mask versus Effect of High Flow Nasal Cannula on oxygenation and haemodynamic parameters. |
|
Scientific Title of Study
|
Comparison of oxygenation using venturi mask and high flow nasal cannula in patients undergoing minor surgery under total intravenous 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 Suneet Kant Kathuria |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Anaesthesia department, Dayanand Medical College and Hospital
Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
9814007622 |
| Fax |
|
| Email |
suneetkathuria@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suneet Kant Kathuria |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Anaesthesia department, Dayanand Medical College and Hospital
Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
9814007622 |
| Fax |
|
| Email |
suneetkathuria@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suneet Kant Kathuria |
| Designation |
Professor |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Anaesthesia department, Dayanand Medical College and Hospital
Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
9814007622 |
| Fax |
|
| Email |
suneetkathuria@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Civil lines Ludhiana, Punjab
Pincode:141001 |
|
|
Primary Sponsor
|
| Name |
DMCH |
| Address |
LUDHIANA
PUNJAB |
| 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 |
| Upasana |
Dayanand Medical College and Hospital |
Departement of Anaesthesia
DMCH,Civil lines ,Tagore Nagar, Ludhiana Punjab
141001
Ludhiana
PUNJAB |
7005205512
upasna.moni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics committee of Dayanand Medical college |
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 |
| Intervention |
Application of Venturi mask and High Flow Nasal Cannula. |
Comparison of oxygenation using Venturi mask and High Flow Nasal Cannula in patients undergoing minor surgery under total intravenous anaesthesia. |
| Comparator Agent |
High Flow Nasal Cannula versus Venturi Mask. |
Comparison of oxygenation using Venturi mask and High Flow Nasal Cannula in patients undergoing minor surgery under total intravenous anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients
patients withBMI<40kg/m2 |
|
| ExclusionCriteria |
| Details |
Morbid obese patients.
patients having pre procedure saturation <90%
peripheral vascular diseases.
Psychiatric/neurological diseases.
Allergic to drugs used in general anaesthesia.
Severe renal,cardiac,respiratory diseases.
patients with anatomical facial defects.
patients with refusal of consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Hypoxia(saturation falling less than 90%). |
Incidence of hypoxia is assesed at every 2 minutes during intraoperative period and at every 10 minutes during postoperative period upto 1 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic instability(more than 20percent fluctuation from baseline)
Need for airway manoeuvres or adjuncts.
Need for supraglottic airway device insertion or intubation.
Patients tolerance of procedure.
|
Haemodynamic parameters are assesed at every 2 minutes during intraoperative period and at every 10 minutes during post operative period upto 1 hour. |
|
|
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)
|
30/12/2020 |
| 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)?
Response - NO
|
|
Brief Summary
|
Comparison of oxygenation using venturi mask and high flow nasal cannula in patients undergoing minor surgery under total intravenous anaesthesia. |