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Supported Ventilation in ARDS Patients

Primary Purpose

Acute Respiratory Distress Syndrome, Mechanical Ventilation, Tidal Volume

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Rocuronium
Sponsored by
University Medical Center Nijmegen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Mechanical Ventilation, Tidal volume, NMBA

Eligibility Criteria

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

Inclusion Criteria:

  • age > 18 year
  • informed consent
  • ARDS according to the Berlin definition
  • RASS -4/-5
  • tidal volume > 8 ml/kg during supported ventilation
  • double balloon esophageal EMG NAVA catheter

Exclusion Criteria:

  • recent use of muscle relaxants / NMBAs (< 3 hours)
  • pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases
  • phrenic nerve lesions
  • elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma)
  • open chest or abdomen
  • pregnancy
  • systolic blood pressure < 90 mm Hg / MAP < 65 mm Hg

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuromuscular blocking agent

Arm Description

Outcomes

Primary Outcome Measures

Feasibility of titrating tidal volume < 6 ml/kg
The feasibility of titrating tidal volume in ARDS patients below 6 ml/kg using NMBA is evaluated in every patient. The outcome measure is dichotomic (yes/no).

Secondary Outcome Measures

Respiratory rate
A secondary outcome measure is the respiratory rate after titration NMBA during different ventilatory modes.
Diaphragm electrical activity
A secondary outcome measure is the root-mean-square of the diaphragm electrical activity after titration NMBA during different ventilatory modes.
Transpulmonary pressure
Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first 2 minutes after titration NMBA during different ventilatory modes.
Transdiaphragmatic pressure
Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first two minutes after titration NMBA during different ventilatory modes.
Neuroventilatory efficiency
A secondary outcome measure is the neuroventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) after titration NMBA during different ventilatory modes.
Neuromechanical efficiency
A secondary outcome measure is the neuromechanical efficiency (i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm after titration NMBA during different ventilatory modes.
Patient-ventilator contribution to breathing
A secondary outcome measure is the patient-ventilator contribution to breathing (i.e. ratio of: the ratio of tidal volume and diaphragm electrical activity without assist, and the ratio of tidal volume and diaphragm electrical acticity with assist) during and after titration of NMBA.
Oxygenation index
A secondary parameter is the oxygenation index which is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen.
Carbon dioxide tension in arterial blood (PaCO2)
A secondary parameter is the carbon dioxide tension in arterial blood.
pH of arterial blood
A secondary parameter is the pH of arterial blood.
Patient-ventilator interaction
Patient-ventilator interaction is evaluated using the NeuroSync index during different ventilatory modes.

Full Information

First Posted
February 12, 2014
Last Updated
December 1, 2014
Sponsor
University Medical Center Nijmegen
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1. Study Identification

Unique Protocol Identification Number
NCT02064140
Brief Title
Supported Ventilation in ARDS Patients
Official Title
Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Nijmegen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV. Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Mechanical Ventilation, Tidal Volume
Keywords
ARDS, Mechanical Ventilation, Tidal volume, NMBA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular blocking agent
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Primary Outcome Measure Information:
Title
Feasibility of titrating tidal volume < 6 ml/kg
Description
The feasibility of titrating tidal volume in ARDS patients below 6 ml/kg using NMBA is evaluated in every patient. The outcome measure is dichotomic (yes/no).
Time Frame
Within 5 minutes after titration of NMBA
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
A secondary outcome measure is the respiratory rate after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA
Title
Diaphragm electrical activity
Description
A secondary outcome measure is the root-mean-square of the diaphragm electrical activity after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Title
Transpulmonary pressure
Description
Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first 2 minutes after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Title
Transdiaphragmatic pressure
Description
Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first two minutes after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Title
Neuroventilatory efficiency
Description
A secondary outcome measure is the neuroventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Title
Neuromechanical efficiency
Description
A secondary outcome measure is the neuromechanical efficiency (i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm after titration NMBA during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.
Title
Patient-ventilator contribution to breathing
Description
A secondary outcome measure is the patient-ventilator contribution to breathing (i.e. ratio of: the ratio of tidal volume and diaphragm electrical activity without assist, and the ratio of tidal volume and diaphragm electrical acticity with assist) during and after titration of NMBA.
Time Frame
During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA
Title
Oxygenation index
Description
A secondary parameter is the oxygenation index which is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen.
Time Frame
Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
Title
Carbon dioxide tension in arterial blood (PaCO2)
Description
A secondary parameter is the carbon dioxide tension in arterial blood.
Time Frame
Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
Title
pH of arterial blood
Description
A secondary parameter is the pH of arterial blood.
Time Frame
Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.
Title
Patient-ventilator interaction
Description
Patient-ventilator interaction is evaluated using the NeuroSync index during different ventilatory modes.
Time Frame
Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 year informed consent ARDS according to the Berlin definition RASS -4/-5 tidal volume > 8 ml/kg during supported ventilation double balloon esophageal EMG NAVA catheter Exclusion Criteria: recent use of muscle relaxants / NMBAs (< 3 hours) pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases phrenic nerve lesions elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma) open chest or abdomen pregnancy systolic blood pressure < 90 mm Hg / MAP < 65 mm Hg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L MA Heunks, MD, PhD
Organizational Affiliation
University Medical Center Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

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Supported Ventilation in ARDS Patients

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