| CTRI Number |
CTRI/2023/08/056930 [Registered on: 25/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Choosing the breathing technique for best oxygenation status before Surgery - A Comparison of Four Methods for patients planned for surgery under General Anesthesia |
|
Scientific Title of Study
|
A study to compare efficacy of four techniques of preoxygenation before induction of general anaesthesia in adults undergoing elective surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swapnil S Dasture |
| Designation |
Anaesthesia Resident |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Operation theater block 5 Department of Anaesthesia and critical care, Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9823284104 |
| Fax |
|
| Email |
lubb4dubb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brig Rahul Yadav |
| Designation |
Professor and Head of Department |
| Affiliation |
Armed Forces Medical College Pune |
| Address |
Operation theater block 5, Department of Anaesthesia and Critical care, Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9350035558 |
| Fax |
|
| Email |
docrahulyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lt Col D V Bhargava |
| Designation |
Associate Professor |
| Affiliation |
AFMC,Pune |
| Address |
Operation theater block 5 Department of Anaesthesia and critical care, Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8135855155 |
| Fax |
|
| Email |
bhargavadv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Armed Forces Medical College Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College Pune |
| Address |
Department of Anaesthesiology Critical Care
Armed Forces Medical College
Sholapur Road
Pune 411040 |
| 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 Rahul Yadav |
Command hospital SC, Pune |
Operation theater block 5, Department of Anaesthesia and critical care, Command Hospital, Golibar Maidan, Pune 411040
Pune
MAHARASHTRA |
9350035558
docrahulyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Armed Forces Medical College,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tidal volume group |
Tidal volume breathing using oxygen at 6 litres per minute by simple face mask
Total duration of the intervention : Less than 5 min |
| Intervention |
Vital capacity group |
Vital capacity breaths at pace comfortable to the patient
Total duration of intervention - Less than 5 min |
| Intervention |
Vital capacity with CPAP |
Vital capacity breaths at pace comfortable to the patient with tight fitting NIV Mask(CPAP 5Cm of water) |
| Intervention |
Vital capacity with Head up |
Vital capacity breaths at a pace comfortable to the patient in head up 30 degrees posture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective surgeries within 18-70 yrs of age group. |
|
| ExclusionCriteria |
| Details |
1) Pediatric age group less than 18 yrs
2) Patients requiring mechanical ventilator support or oxygen support of any kind before the induction of anaesthesia before elective surgery.
3) ASA 4
4) Term pregnancy for elective LSCS |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Name of the drug:Inhaled Oxygen gas
Duration: Less than 5 min
Achieving the EtO2 Of 90% is the primary outcome
To determine the time required for adequate preoxygenation i.e End tidal Oxygen of 90%. |
The time taken to achieve end-tidal O2 of 90% while breathing 100% oxygen by various methods studied will be noted.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
age
gender
body mass index
body surface area
lung disease |
We will check factors affecting during the procedure & At the end of preoxygenation. Total duration of the procedure is less than 5min
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/09/2023 |
| 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="6"
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
|
1. Preoxygenation aims to increase the oxygen
stores physiologically to increase the time before desaturation starts
occurring. In the case of a rapid sequence of intubation when positive pressure
is not preferred before intubation, denitrogenation is another way to look at
preoxygenation as the place of oxygen is being taken by high inspired oxygen
concentration.
2. Optimal preoxygenation allows you to increase
the oxygen stores in the body. Preoxygenation is mostly achieved when
almost all of the compartments like alveolar, tissue, and venous components are
filled with oxygen.
3. Patients with less functional residual
capacity, hemoglobin concentration, reduced cardiac output, and increased
oxygen demand in the body tend to desaturate at a faster rate than normal patients.
These types of patients generally need optimal preoxygenation.
4. Difficult intubation may not always be predictable.
In these cases, preoxygenation again becomes important and hence, performed in
all patients for the same reason. Only very uncooperative patients of any age
group can be considered as only an exclusion. Preventable but main reasons are failure
to attain the FAo2 and inadequate time of preoxygenation Aim of Study: To compare the efficacy of four
different techniques of preoxygenation before induction of general anaesthesia
for elective surgery. Objectives: Primary Objective: To determine the time required for
adequate preoxygenation i.e. End tidal oxygen of 90% using four different
methods. Secondary objective: To determine the various factors
affecting adequate preoxygenation before induction of general anaesthesia for
elective surgery in adult population. Study Design: Prospective
randomized trial Patients will be randomly allocated in the four different groups: Group
A: Eight vital capacity breaths at a pace comfortable to the patient. Group
B: Tidal volume breathing using oxygen at 6 lpm by face mask. Group
C: Tight fitting NIV mask (CPAP 5 cm of Water).
Group
D: Eight vital capacity breaths at a pace comfortable to the patient in Head up
30degree posture.
|