| CTRI Number |
CTRI/2025/02/080319 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of volume controlled ventilation versus pressure controlled ventilation on respiratory functions and duration of ventilatory requirement with severe pulmonary arterial hypertension postoperatively posted for intrathoracic repairs
|
|
Scientific Title of Study
|
Effects of volume-controlled ventilation versus pressure controlled ventilation on perioperative respiratory functions and postoperative ventilator requirement, in patients posted for intracardiac repair for congenital heart diseases with severe PAH.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharayu Paunikar |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anesthesia , Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8793148024 |
| Fax |
|
| Email |
sharayuru02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Chakole |
| Designation |
Professor and Head of department, Department of Anesthesia JNMC |
| Affiliation |
Acharya Vinobha Bhave Rural Hospital, JMNC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College,
Datta Meghe Institute of Higher Education and Research, Sawangi
(Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharayu Paunikar |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anesthesia , Jawaharlal Nehru Medical College, Datta Meghe Cnstitute of Higher Education and Research, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
8793148024 |
| Fax |
|
| Email |
sharayuru02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe,Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Sharayu Paunikar |
| Address |
Department of Anesthesia , Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe , Wardha , India 442001 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Sharayu Paunikar |
Datta Meghe institute of higher education and research |
Department of Anesthesia , Jawaharlal Nehru medical college, Datta Meghe institute of higher education and research, Sawangi (Meghe) , Wardha , India
Wardha
MAHARASHTRA |
8793148024
sharayuru02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I288||Other diseases of pulmonary vessels, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pressure controlled ventilation |
In patients with congenital heart disease with severe PAH respiratory rate will be adjusted to maintain an end tidal carbon dioxide in the range of 30-35mmHg. Duration of postoperative ventilator requirement will be observed for 24 hours minimum. |
| Intervention |
Volume controlled ventilation |
In patients with congenital heart disease with severe PAH respiratory rate will be adjusted to maintain an end tidal carbon dioxide in the range of 30-35mmHg. Duration of postoperative ventilator requirement will be observed for 24 hours minimum. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with severe PAH
Patients slated to undergo intrathoracic surgeries.
Patients who provide valid informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with mild to moderate PAH,
Patients with pre-existing lung disorders,
Patients with severe diseases of the cardiovascular, respiratory, and neurological systems.
Patients with low left ventricular ejection fraction,
Patients with impaired renal and hepatic parameters,
Patients posted for emergency procedures
Patients who will require one-lung ventilation for the procedures
Patients not giving a valid consent to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effects of Volume-Controlled Ventilation Versus Pressure Controlled Ventilation on Respiratory Functions and Duration of Ventilatory Requirement, Postoperatively, in Patients with Severe PAH, Posted for Intrathoracic Repairs |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Raised blood pressure levels in the pulmonary arteries cause pulmonary
arterial hypertension (PAH), a rare but potentially fatal illness that severely
impairs lung function and causes right heart failure. Respiratory problems are a significant concern
throughout the perioperative phase for individuals with severe PAH who require
intrathoracic surgical procedures. Selecting a mechanical
ventilation approach for these patients is a crucial part of their
perioperative care. Two popular types of mechanical ventilation,
with pros and cons, are Volume-Controlled Ventilation (VCV) and
Pressure-Controlled Ventilation (PCV). By methodically comparing the effects of pressure-controlled ventilation
(PCV) and volume-controlled ventilation (VCV) on respiratory functions and the
length of ventilatory support in patients with severe PAH who are posted for
intrathoracic repairs, this study seeks to address this critical knowledge gap.
Compromised respiratory and cardiovascular systems are standard in patients
with severe PAH. The decision between VCV and PCV must consider factors such as total
respiratory efficiency, hemodynamic stability, and lung protection—all of which
are critical to the health of these high-risk patients. This study seeks to
provide critical evidence-based insights about the most appropriate ventilation
method for patients with severe PAH having intrathoracic repairs, as there is
currently no consensus in the literature and clinical practice in this area. |