| CTRI Number |
CTRI/2024/04/065019 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of co2 on arterial oxygenation during one lung ventilation. |
|
Scientific Title of Study
|
A Randomized comparative study to compare the effect of normocarbia vs permissive hypercarbia on arterial oxygenation during one lung ventilation in lung surgeries at SMS medical college , jaipur |
| 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 |
Sms medical college , jIpur |
| Address |
Department of anaesthesia
2nd floor , Dhanwantri block
Sms medical college, jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
94139622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Indu verma |
| Designation |
Senior professor |
| Affiliation |
Sms medical college , jIpur |
| Address |
Department of anaesthesia
2nd floor , Dhanwantri block
Sms medical college, jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
94139622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anjana Kumari meena |
| Designation |
PG Resident |
| Affiliation |
Sms medical college |
| Address |
Department of anaesthesia 2nd floor Dhanwantri block
Sms medical college, jaipur
Jaipur RAJASTHAN 302004 India |
| Phone |
7204223591 |
| Fax |
|
| Email |
anjanakumarimeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia 2nd floor Dhanwantri block, sms medical college jaipur |
|
|
Primary Sponsor
|
| Name |
Sms medical college |
| Address |
Sms medical college and attached hospitals
Jaipur
302004 |
| 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, jaipur |
Cardiac operation theater,
2nd floor, Department of anaesthesia 2nd floor Dhanwantri block 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 and attached hospitals, jaipur |
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 |
| Intervention |
Hypercarbia |
During one lung ventilation we will maintain permissive hypercarbia upto 50 by changing respiratory rate for 30minutes |
| Comparator Agent |
Normocarbia |
We will maintain normocarbia during one lung ventilation by changing respiratory rate for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years
ASA grade 1 to 3
Patients undergoing elective lung surgeries (thoracotomy, pneumonectomy, lobectomy, bilobectomy, segmentectomy etc.)
Patients who will give informed written consent |
|
| ExclusionCriteria |
| Details |
1.Patient should not be a part of other study.
2.Non co-operative patient.
3 .Patient who presented with cardiac arrhythmias
4. History of heart failure, vascular disease, chronic obstructive pulmonary disease, restrictive pulmonary disease or increased increased intracerebral pressure
5. Evidence of any liver or kidney disease
6. Patients with haemostatic disorders
7. Previously existing chronic respiratory disease of non-operated lung
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean PaO2 in both study group.
Mean change in haemodynamic variables- HR,SBP,DBP,MAP
Mean change in respiratory variables - Pmean, Pplateau, dynamic compliance etc
|
Baseline , after 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in heamodynamic variables and respiratory variables |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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 4 |
|
Date of First Enrollment (India)
|
07/04/2024 |
| 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="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
|
One
lung ventilation has become accepted procedure where lung isolation and
sepration is required in thoracic surgeries . During one lung ventilation (OLV)
diseased lung is collapsed which is being operated while
ventilation of the other lung is required to facilitate better surgical access and visibility in lung
surgeries. We use double-lumen
endotracheal tubes (DLT) or bronchial blocker for OLV. This technique
helps to prevent contamination of normal lung and improve surgical ability.
During
one-lung ventilation (OLV) the
nonventilated lung remains perfused but not ventilated, leading to an increase
in shunt fraction and a decrease in oxygenation. This obligatory intrapulmonary
shunt may produce hypoxemia because of collapse of the nondependent lung and
increased atelectatic areas in the dependent lung. It leads to ventilation
-perfusion mismatch.
Hypoxic
Pulmonary Vasoconstriction shunts divert
blood
away from poorly oxygenated areas to
better ventilated lung segments, thereby optimizing ventilation-perfusion
matching, reducing shunt fraction and optimizing systemic O2 delivery.
Oxygenation
during OLV can be improved by increasing blood flow to the ventilated lung or
decreasing blood flow to the nonventilated lung.
Carbon
dioxide is a potent vasodilator in cerebral and systemic circulation. However
the effect of CO2 on pulmonary circulation is unclear.
Permissive hypercapnia refers
to the ventilator strategy that allows the Pco2 to rise in a controlled
fashion in an effort to reduce lung injury and the burden of gas exchange.
Although a Pco2 value of 40 mm Hg is considered normal in healthy humans,
higher values may be adaptive in disease. Permissive hypercapnia can
be achieved by reductions in respiratory rate or tidal volume, or both.
In
this study, we tested the hypothesis that
hypercarbia within permissible limits may have effect in improving arterial oxygenation
compared to normocarbia during OLV in patients undergoing lung
surgeries. |