transpulmonary pressure guided ventilation in ARDS
- 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
- 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.
- 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
Name Time Method Improvement in PaO2 /FiO2 ratio outcomes measured at baseline, at 6 and 12 hours respectively. Improvement in static compliance outcomes measured at baseline, at 6 and 12 hours respectively. VILI like spontaneous pneumothorax outcomes measured at baseline, at 6 and 12 hours respectively. Improvement in CO2 exchange outcomes measured at baseline, at 6 and 12 hours respectively.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
dayanand hospital
🇮🇳Ludhiana, PUNJAB, India
dayanand hospital🇮🇳Ludhiana, PUNJAB, IndiaDr ravi krishnaPrincipal investigator917799325566mravikrishna23@gmail.com