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Clinical Trials/NCT04435613
NCT04435613
Completed
Not Applicable

Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients

Clinica las Condes, Chile1 site in 1 country10 target enrollmentSeptember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Clinica las Condes, Chile
Enrollment
10
Locations
1
Primary Endpoint
To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied

Detailed Description

Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact. Baseline: All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study. Protocol design: Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW). After 30 minutes of continuous monitoring, minute ventilation, mechanical power, variables obtained by volumetric capnography, and arterial blood gases were recorded in each study phase. This study will be performed in the Intensive Care Unit of a University Hospital.

Registry
clinicaltrials.gov
Start Date
September 4, 2019
End Date
August 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Clinica las Condes, Chile
Responsible Party
Principal Investigator
Principal Investigator

Martin Benites

Principal Investigator: Martín Hernán Benites Albanese

Clinica las Condes, Chile

Eligibility Criteria

Inclusion Criteria

  • Age older than 18 years
  • The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
  • Severe hypoxemia (PAFI \< 200) secondary to ARDS

Exclusion Criteria

  • Heart failure stage IV
  • Chronic obstructive pulmonary disease (COPD) on home oxygen
  • Bronchopulmonary fistula
  • Hypovolemic Shock with active hemorrhage
  • Gastrointestinal bleeding
  • Oesophageal Varices
  • Nasopharynx surgery, recent oesophageal or gastric surgery
  • Massive Pulmonary Thromboembolism
  • Catastrophic respiratory failure requiring urgent extracorporeal life support
  • Respiratory acidosis. Hydrogen potential (pH) is less than 7.20 and PaCO2 higher than 60 mmHg at baseline.

Outcomes

Primary Outcomes

To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome

Time Frame: 150 minutes

After the systematic reduction of the tidal volume, end-inspiratory pause prolongation, and the reduction of the respiratory rate, the optimisation of the dead space and the alveolar ventilation could be generated.

Study Sites (1)

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