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transpulmonary pressure guided ventilation in ARDS

Phase 3
Not yet recruiting
Conditions
Respiratory disorders in diseasesclassified elsewhere,
Registration Number
CTRI/2021/03/032431
Lead Sponsor
self
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

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in PaO2 /FiO2 ratiooutcomes measured at baseline, at 6 and 12 hours respectively.
Improvement in static complianceoutcomes measured at baseline, at 6 and 12 hours respectively.
VILI like spontaneous pneumothoraxoutcomes measured at baseline, at 6 and 12 hours respectively.
Improvement in CO2 exchangeoutcomes measured at baseline, at 6 and 12 hours respectively.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

dayanand hospital

🇮🇳

Ludhiana, PUNJAB, India

dayanand hospital
🇮🇳Ludhiana, PUNJAB, India
Dr ravi krishna
Principal investigator
917799325566
mravikrishna23@gmail.com

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