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Clinical Trials/NCT04141293
NCT04141293
Withdrawn
Not Applicable

Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged1 site in 1 countryAugust 1, 2017
ConditionsARDS, Human

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS, Human
Sponsor
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Locations
1
Primary Endpoint
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

According to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. Undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. These effects can be more pronounced in patients suffering from ARDS, a condition commonly accompanied by hemodynamic instability. The complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver.

Previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. Following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. However, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations.

The primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. In the meantime, hemodynamic changes are monitored by PiCCO and transthoracic echocardiography, and lung field aeration by electric impedance tomography.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
November 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
Responsible Party
Principal Investigator
Principal Investigator

András Lovas

Head of Department

Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged

Eligibility Criteria

Inclusion Criteria

  • orotracheal intubation
  • pressure supported ventilation
  • moderate-to-severe hypoxemic respiratory failure according to ARDS Berlin Criteria Moderate: 100 Hgmm ≤ PaO2/FiO2 ≤ 200 Hgmm, PEEP ≥ 5 cmH2O Severe: PaO2/FiO2 ≤ 100 Hgmm, PEEP ≥ 5 cmH2O

Exclusion Criteria

  • age \< 18 years
  • pregnancy
  • previous pulmonary resection, pulmonectomy
  • clinically verified, end-stage COPD
  • severe hemodynamic instability (i.e. refractory shock to vasopressors)
  • severe emphysema and/or spontaneous pneumothorax in past medical history
  • contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)

Outcomes

Primary Outcomes

Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment

Time Frame: Approximately 35 minutes

Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations

Secondary Outcomes

  • Changes in pulmonary air content(Approximately 30 miniutes)
  • Changes in arterial oxygen content(Approximately 5 minutes)
  • Changes in hemodynamic parameters (SV)(35 minutes)
  • Changes in hemodynamic parameters (MAP)(35 minutes)
  • Changes in hemodynamic parameters (HR)(35 minutes)
  • Changes in hemodynamic parameters (CI)(35 minutes)
  • Changes in left and right ventricular volume (systolic ventricular interdependence)(Approximately 3 minutes)

Study Sites (1)

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