| CTRI Number |
CTRI/2023/11/059998 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
19/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to assess the effects of Different Positive End Expiratory Pressure (PEEP) Levels for evaluation of improvement in PaO2(gas exchange) by doing serial ABG in patients undergoing One Lung Ventilation in thoracic surgeries under general anesthesia. |
|
Scientific Title of Study
|
A descriptive study to assess the effects of different positive end expiratory pressure (PEEP) levels for evaluation of improvement in Gas exchange in Patients undergoing One Lung Ventilation in thoracic surgeries |
| 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. Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Maan Singh Medical College And Hospital |
| Address |
Department of Anesthesia CTOT 2nd floor SMS Medical college , JLN MARG,Jaipur 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Maan Singh Medical College And Hospital |
| Address |
Department of Anesthesia CTOT 2nd floor SMS Medical college , JLN MARG,Jaipur 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nivedita Dagar |
| Designation |
PG Resident |
| Affiliation |
SMS Medical College And Hospital |
| Address |
Department of Anesthesia CTOT 2nd Floor SMS Hospital ,JLN Marg ,jaipur , rajasthan
302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
8209985737 |
| Fax |
|
| Email |
niveditadagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anesthesio;ogy 2nd floor Dhanvantri complex,SMS medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Sawai Maan Singh Medical college and hospital |
| Address |
Department OF Anesthesiology second floor ,Dhanvantri Complex,SMS medical college ,jaipur |
| 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 Indu Verma |
SMS Medical College And Hospital |
Depaertment Of Anesthesia ,Second Floor, Dhanvantri Complex , SMS Medical College , Jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
) Pt. willing to give written and Informed consent.
2) Age >18yrs
3) Patient undergoing Elective thoracic Surgery.
4) ASA Grade- II and III
5) OLV lasting ≥ 60mins
|
|
| ExclusionCriteria |
| Details |
lung reduction surgery
Pneumonectomy
patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) < 60% presence of large bullae, pleural diseases and/or acute or chronic.
uncompensated cardiac disease.
ASA Grade –IV
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect of various PEEP levels on PaO2/FiO2 ratio by ABG analysis |
45minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic variation like Heart Rate, Systolic BP, Diastolic BP.
2.Various complications
|
70mins |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/12/2023 |
| 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="0"
Months="3"
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
|
Our aim is to evaluate the effect of various PEEP(positive end expiratory pressure) levels on PaO2 (gas exchange) in one lung ventilation in patients undergoing thoracic surgery under general anesthesia.
|