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

Primary Purpose

ARDS, Human

Status
Suspended
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
alveolar recruitment
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Szeged, Department of Anesthesiology and Intensive Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eligible patients

Arm Description

Outcomes

Primary Outcome Measures

Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment
Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations

Secondary Outcome Measures

Changes in left and right ventricular volume (systolic ventricular interdependence)
Left ventricular end-systolic eccentricity index will be assessed by transthoracal echocardiogarphy and will be compared with transpulmonary pressure alterations.
Changes in pulmonary air content
Changes in pulmonary atelectasis will be assessed by electrical impedance tomography (EIT) - mean impedance variation in % and will be compared with arterial oxygen content.
Changes in arterial oxygen content
Pre- and post-recruitment arterial oxygenation (PaO2 mmHg) will be measured by blood gas machine and will be compared to EIT measurements.
Changes in hemodynamic parameters (SV)
Changes in stroke volume (ml)
Changes in hemodynamic parameters (MAP)
Changes in mean arterial pressure (mmHg)
Changes in hemodynamic parameters (HR)
Changes in heart rate (1/min)
Changes in hemodynamic parameters (CI)
Changes in cardiac index (l/min/2m)

Full Information

First Posted
August 30, 2017
Last Updated
October 25, 2019
Sponsor
Szeged University
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1. Study Identification

Unique Protocol Identification Number
NCT04141293
Brief Title
Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation
Official Title
Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Support Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Suspended
Why Stopped
Technical problems and employee shortage
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eligible patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
alveolar recruitment
Intervention Description
Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.
Primary Outcome Measure Information:
Title
Comparison of transpulmonary pressure and hemodynamic changes during alveolar recruitment
Description
Changes in transpulmonary pressure during alveolar recruitment will be compared to the subsequent hemodynamic alterations
Time Frame
Approximately 35 minutes
Secondary Outcome Measure Information:
Title
Changes in left and right ventricular volume (systolic ventricular interdependence)
Description
Left ventricular end-systolic eccentricity index will be assessed by transthoracal echocardiogarphy and will be compared with transpulmonary pressure alterations.
Time Frame
Approximately 3 minutes
Title
Changes in pulmonary air content
Description
Changes in pulmonary atelectasis will be assessed by electrical impedance tomography (EIT) - mean impedance variation in % and will be compared with arterial oxygen content.
Time Frame
Approximately 30 miniutes
Title
Changes in arterial oxygen content
Description
Pre- and post-recruitment arterial oxygenation (PaO2 mmHg) will be measured by blood gas machine and will be compared to EIT measurements.
Time Frame
Approximately 5 minutes
Title
Changes in hemodynamic parameters (SV)
Description
Changes in stroke volume (ml)
Time Frame
35 minutes
Title
Changes in hemodynamic parameters (MAP)
Description
Changes in mean arterial pressure (mmHg)
Time Frame
35 minutes
Title
Changes in hemodynamic parameters (HR)
Description
Changes in heart rate (1/min)
Time Frame
35 minutes
Title
Changes in hemodynamic parameters (CI)
Description
Changes in cardiac index (l/min/2m)
Time Frame
35 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Szeged, Department of Anesthesiology and Intensive Therapy
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
26682219
Citation
Lovas A, Szakmany T. Haemodynamic Effects of Lung Recruitment Manoeuvres. Biomed Res Int. 2015;2015:478970. doi: 10.1155/2015/478970. Epub 2015 Nov 22.
Results Reference
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PubMed Identifier
25954744
Citation
Lovas A, Nemeth MF, Trasy D, Molnar Z. Lung recruitment can improve oxygenation in patients ventilated in continuous positive airway pressure/pressure support mode. Front Med (Lausanne). 2015 Apr 21;2:25. doi: 10.3389/fmed.2015.00025. eCollection 2015.
Results Reference
background
PubMed Identifier
24597883
Citation
Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.
Results Reference
background
PubMed Identifier
22797452
Citation
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
Results Reference
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Hemodynamic Effects of Changes in Transpulmonary Pressure During Recruitment Maneuver in Patients Under Pressure Supported Mechanical Ventilation

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