| CTRI Number |
CTRI/2024/10/075851 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check blood oxygen and carbon dioxide levels during open heart bypass operation , by taking blood samples and sending for a test called Arterial blood gas ,which will help us to treat any complications earlier. |
|
Scientific Title of Study
|
To analyze the utility of deltaPCO2 gap / AVO2 content difference ratio in the assessment of tissue hypoperfusion secondary to low cardiac output state during obtuse marginal artery distal anastomosis in off-pump coronary artery bypass grafting. |
| 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 Shravan Gowtham v |
| Designation |
Postgraduate |
| Affiliation |
Mahatma Gandhi medical college and research institute |
| Address |
Room no:211, Department of Anaesthesiology and pain medicine,Second floor , Hospital block , Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9677487827 |
| Fax |
|
| Email |
shravanmittu1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anity Singh |
| Designation |
Assistant professor |
| Affiliation |
Mahatma Gandhi medical college and research institute |
| Address |
Room no:211, Department of Cardiac Anaesthesia , Second floor , Hospital block, Mahatma Gandhi medical college and research institute,Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9994495307 |
| Fax |
|
| Email |
dranity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anity Singh |
| Designation |
Assistant professor |
| Affiliation |
Mahatma Gandhi medical college and research institute |
| Address |
Room no:211, Department of Cardiac Anaesthesia , Second floor , Hospital block, Mahatma Gandhi medical college and research institute,Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9994495307 |
| Fax |
|
| Email |
dranity@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi medical college and research institute, Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college and research institute, Pondicherry |
| Address |
Pondicherry Cuddalore road, ECR, Puducherry 607402 |
| 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 |
| Dr Shravan Gowtham V |
Mahatma Gandhi medical college and research institute |
Room no:211, Department of Anaesthesiology and pain medicine ,second floor , Hospital block, Pondicherry
Pondicherry
PONDICHERRY |
9677487827
shravanmittu1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Written informed consent
Age more than 18 years
Elective off‑pump coronary artery bypass graft surgery
Preoperative hemoglobin more than or equal to 10 g/dl
Central venous saturation-ScvO2 more than or equal to 70%
American Society of Anaesthesiology -ASA Grade 2, 3 and 4
|
|
| ExclusionCriteria |
| Details |
Left ventricular ejection fraction of less than 35%
Unstable angina pectoris
Heart failure with New York Heart Association class III‑IV
Acute myocardial infarction within the last 2 weeks
Previous CABG surgery
Patients with chronic obstructive pulmonary disease
On-table conversion to Cardiopulmonary bypass surgery
known uncorrected valvular incompetence or intracardiac shunting
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate DeltaPCO2 gap / AVO2 content difference ratio around the time of Obtuse marginal artery distal anastomosis during off-pump coronary artery bypass grafting |
As a baseline after inserting central venous and arterial access under local anesthesia-T0
Just prior to skin incision-T1
Next will be 5 min after flow to LAD has been established-T2
Subsequently 5 min after the distal anastomosis to OM and settling the heart into its normal anatomical position -T3
The mixed venous sample at T2 and T3 will be taken by the operating surgeon, from the main pulmonary artery through a purse-string suture for safety. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To calculate DeltaPCO2 gap PaCO2 – PcvO2, to analyze its correlation with tissue ischemia.
2. To analyze the comparability of using central venous and mixed venous partial pressure of CO2, DeltaPCO2 gap (PaCO2 – PcvO2) and DeltaPCO2 gap /C(a-cv)O2 ratio.
|
As a baseline after inserting central venous and arterial access under local anesthesia-T0
Just prior to skin incision-T1
Next will be 5 min after flow to LAD has been established-T2
Subsequently 5 min after the distal anastomosis to OM and settling the heart into its normal anatomical position -T3
The mixed venous sample at T2 and T3 will be taken by the operating surgeon, from the main pulmonary artery through a purse-string suture for safety. |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
21/11/2024 |
| 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="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dranity@gmail.com].
- For how long will this data be available start date provided 05-04-2026 and end date provided 05-09-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study has been designed as a prospective observational cohort study and 57 patients scheduled for elective off-pump CABG surgery will be included in the study. We will analyze the utility of DeltaPCO2 gap / AVO2 content difference ratio in the assessment of tissue hypoperfusion secondary to low cardiac output state during Obtuse marginal artery distal anastomosis in off-pump coronary artery bypass grafting. Our Primary objective will be to calculate DeltaPCO2 gap / AVO2 content difference ratio around the time of Obtuse marginal artery distal anastomosis during off-pump coronary artery bypass grafting. The secondary outcomes will be to calculate DeltaPCO2 gap (PaCO2 – PcvO2), to analyze its correlation with tissue ischemia and to analyze the comparability of using central venous and mixed venous partial pressure of CO2, DeltaPCO2 gap (PaCO2 – PcvO2) and DeltaPCO2 gap /C(a-cv)O2 ratio. |