| CTRI Number |
CTRI/2021/03/032431 [Registered on: 30/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
transpulmonary pressure guided ventilation in ARDS |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF TRANSPULMONARY PRESSURE GUIDED VENTILATION VERSUS CONVENTIONAL VENTILATION IN PATIENTS WITH A.R.D.S |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Ravi krishna |
| Designation |
senior resident |
| Affiliation |
dayanand medical college and hospital |
| Address |
Department of critical care, ICU block, 4th floor, Dayanand hospital, civil lines, tagore nagar
Ludhiana
PUNJAB
141001
India |
| Phone |
07799325566 |
| Fax |
|
| Email |
m.ravikrishna23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P L Gautam |
| Designation |
Head of department |
| Affiliation |
dayanand medical college and hospital |
| Address |
Department of Critical Care, ICU block, 4th floor, Dayanand medical college and hospital, civil lines, Tagore nagar
Ludhiana
PUNJAB
141001
India |
| Phone |
9876331565 |
| Fax |
|
| Email |
drplgautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ravi krishna |
| Designation |
Senior Resident |
| Affiliation |
dayanand medical college and hospital |
| Address |
Department of critical care,ICU block, 4th floor, Dayanand medical college and hospital, civil lines, Tagore nagar
Ludhiana
PUNJAB
141001
India |
| Phone |
07799325566 |
| Fax |
|
| Email |
m.ravikrishna23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand hospital, civil lines, tagore nagar, ludhiana, punjab |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of critical care, ICU block, 4th floor, Dayanand medical college and hospital, civil lines, Tagore nagar |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ravi krishna |
dayanand hospital |
Room no .402, 403, 404, ICU block, 4th floor
Ludhiana
PUNJAB |
917799325566
mravikrishna23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| research and ethics committee, dayanand medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional ventilation |
Patients in the control group will be treated according to the low-tidal-volume strategy reported by the ARDS Net study of the National Heart, Lung, and Blood Institute.8These patients will be ventilated using volume control mode with the tidal volume set at 6 ml per kilogram of predicted body weight and PEEP is based on the patient’s PaO2 and FiO2. |
| Intervention |
transpulmonary presssure measurement |
While undergoing treatment, the subjects will be supine, with the head of the bed elevated to 30 degrees. Airway pressure, tidal volumes and other respiratory parameters will be recorded during mechanical ventilation.
An esophageal balloon catheter will be passed to a depth of 60 cms. from the incisors for measurement of gastric pressure and then withdrawn to a depth of 40 cms. to record esophageal pressure during mechanical ventilation. Placement of the balloon in the stomach will be confirmed by a transient increase in pressure during a gentle compression of the abdomen and by a qualitative change in the pressure tracing (i.e., an increased cardiac artifact) as the balloon will be withdrawn into the esophagus.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be included in the study if they have moderate-to-severe ARDS according to the American-European Consensus Conference definitions.
Duration of ARDS 36 hours or less from meeting final Berlin criterion
Age more than 18 years.
|
|
| ExclusionCriteria |
| Details |
Received mechanical ventilation more than 96 h.
Recently treated for bleeding varices, stricture, haematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement.
History of lung or liver transplantation.
Severe chronic liver disease (Child-Pugh Score ≥12).
Patients not committed to full support.
Inability to get informed consent from the patient or surrogate.
Use of rescue therapies prior to enrolment (including nitric oxide, ECMO, prone positioning)
Evidence of active air leak from the lung (including bronchopleural fistula, pneumothorax, pneumomediastinum or air leak from existing chest tube).
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in PaO2 /FiO2 ratio
Improvement in static compliance
VILI like spontaneous pneumothorax
Improvement in CO2 exchange |
outcomes measured at baseline, at 6 and 12 hours respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: As per ARDS net study mechanical-ventilation strategies that use lower end-inspiratory (plateau) airway pressures, lower tidal volumes (VT), and higher positive end-expiratory pressures (PEEPs) can improve survival in patients with the acute respiratory distress syndrome (ARDS)1, but the optimal pressures are not known. Transpulmonary pressure guided ventilation may be beneficial in such patients without the drawback of conventional ventilation strategy. Aim of Study: Our aim is to compare the effect of transpulmonary pressure guided ventilation versus conventional ventilation in patients with A.R.D.S. Materials & Methods: A randomized prospective cross-over study will be conducted on 100 patients of moderate to severe A.R.D.S. Patients will be randomly allocated into two groups. Group T will receive transpulmonary pressure guided ventilation and Group C will receive conventional ventilation. The patients in each group will cross over to the opposite group after a washout period. Clinical Significance: This study will help us to find out if transpulmonary pressure guided ventilation improves ventilation parameters |