| CTRI Number |
CTRI/2019/06/019488 [Registered on: 03/06/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Device Validation |
| Study Design |
Other |
|
Public Title of Study
|
Association of right heart pressure values and/or ECHO readings with respiratory movements in patients undergoing cardiac surgery |
|
Scientific Title of Study
|
Correlation of Swan-Ganz catheter readings and/or Transesophageal
Echocardiogram (TEE) with Barocardiogram (BCG) in Perioperative
Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRD-02-1467 Rev. 01, version 1.0 dated 6th March 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Julius Punnen |
| Designation |
Consultant Cardiothoracic Surgeon |
| Affiliation |
Narayana Hrudayalaya Ltd |
| Address |
# 258/A, Bommasandra Industrial Area, Anekal Taluk
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9980072785 |
| Fax |
|
| Email |
julius.punnen.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Julius Punnen |
| Designation |
Consultant Cardiothoracic Surgeon |
| Affiliation |
Narayana Hrudayalaya Ltd |
| Address |
# 258/A, Bommasandra Industrial Area, Anekal Taluk
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9980072785 |
| Fax |
|
| Email |
julius.punnen.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alben Sigamani |
| Designation |
Group Head - Clinical Reserach |
| Affiliation |
Narayana Hrudayalaya Ltd |
| Address |
# 258/A, Bommasandra Industrial Area, Anekal Taluk
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
8884431444 |
| Fax |
|
| Email |
alben.sigamani.dr@narayanahealth.org |
|
|
Source of Monetary or Material Support
|
| Respirix, Inc.
101 Mississippi Street
San Francisco, CA 94107
Phone: 415-926-8616 |
|
|
Primary Sponsor
|
| Name |
Respirix Inc |
| Address |
101 Mississippi Street
San Francisco, CA 94107, Phone: 415-926-8616 |
| Type of Sponsor |
Other [Company ] |
|
|
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 Julius Punnen |
Narayana Institute of Cardiac Sciences |
Narayana Institute of cardiac sciences, a unit of Narayana Hrudayalaya Ltd, #258/A, Bommasandra Industrial Area, Anekal Taluk
Bangalore Rural
KARNATAKA |
9980072785
julius.punnen.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient must ≥ 18 years of age
2.Scheduled for either: Cardiac valve replacement and/or repair (surgical or transcatheter)
AND/OR Coronary artery bypass grafting (CABG)
3.Patient will receive Swan Ganz Catheter and/or intraoperative Transesophageal Echocardiogram
4. Able to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Subjects who, at the principal investigator’s determination, would not tolerate a 10 second ventilator pause.
2. Subjects who, at the principal investigator’s determination, would not be appropriate for this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify, and, if possible, validate any observed relationships between BCG and TEE and/or Swan-Ganz catheter
measurements. |
1. One measurement before the chest is opened
2. One measurement with open chest
3.One measurement before closure of chest
4. One measurement after chest closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/06/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Cardiospire device is a non-invasive home-use device that has the ability to detect minor, cyclic waveforms caused by cardiac pulses, or cardiogenic oscillations (COS) in the bulk pressure and flow measurements of expiration. The COS waveform is caused by blood, after being ejected from the right ventricle, pulsing through the pulmonary vasculature, which cyclically expands/contracts against the lung tissue and causes a flow/pressure pulsation in air within the airway. Accordingly, features of the COS waveform provide information about cardiac and pulmonary function. Measurements of these COS waveforms from the patient airway have significant potential to diagnose disorders of the cardiovascular and respiratory systems; we refer to these COS recordings as barocardiogram (BCG).
In a previous study we monitored BCG in post-operative cardiac surgery patients by monitoring pressure in the endotracheal tube during a short pause in ventilation and demonstrated that the BCG is both (1) highly repeatable and (2) responsive to pre-load dependent patients.
In this study, we aim to evaluate and quantify the relationships between BCG and parameters determined using Swan-Ganz catheters and/or TEE in cardiac surgery patients.
|