| CTRI Number |
CTRI/2020/12/029550 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
02/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of different concentration of oxygen given introperatively on postoperative gas exchange |
|
Scientific Title of Study
|
Effect of different fraction of inspired oxygen given intraoperatively on postoperative gas exchange: An Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesiology and Critical Care, AIIMS JODHPUR
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesiology and Critical Care, AIIMS JODHPUR
RAJASTHAN
342005
India |
| Phone |
09780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesiology and Critical Care, AIIMS JODHPUR
RAJASTHAN
342005
India |
| Phone |
09780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Kamlesh Kumari |
AIIMS Jodhpur |
Department of Anesthesiology and Critical Care, AIIMS JODHPUR
Jodhpur
RAJASTHAN |
09780040150
kamlesh.gmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologists (ASA) physical status grade I and II, 18-65 years of age scheduled for elective surgery under general anaesthesia will be enrolled |
|
| ExclusionCriteria |
| Details |
Patients posted for or having history of cardio-thoracic surgery, use of intraoperative nitrous oxide, requirement of postoperative mechanical ventilation, patients with cardiac/respiratory disorders, morbid obesity (BMI >40 kg/m2), active upper or lower airway infection, abnormal preoperative chest Xâ€ray findings will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of different fraction of inspired oxygen on postoperative PaO2/FIO2 ratio |
Preoperatively, Postextubation, Postoperatively 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe severity of atelectasis by lung ultrasound |
Preoperatively, Postoperatively |
| To observe incidence of postoperative nausea and vomiting |
Till 24 hour postoperatively |
| To observe incidence of surgical site infection |
Postoperative Day 5 |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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 |
|
Date of First Enrollment (India)
|
10/12/2020 |
| 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="6"
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
|
The present observational study is planned to observe the effect of different fraction of inspired oxygen given intraoperatively on postoperative gas exchange as indicated by PaO2/FiO2 ratio, postoperative nausea and vomiting, and postoperative surgical site infection. |