Diaphragm Protective Ventilation in the Intensive Care Unit (DiaPro)
Primary Purpose
Critical Illness, Muscle Weakness, Muscle Damage
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Titration of support level
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Critical illness associated diaphragm weakness, Mechanical ventilation, Critical illness, Respiratory muscle dysfunction
Eligibility Criteria
Inclusion Criteria:
- Informed consent
- Receives partially supported mechanical ventilation
- Estimated duration of mechanical ventilation after inclusion of at least 24 hours, as estimated by the attending physician
Exclusion Criteria:
- Known neuromuscular disease
- Contra-indications for nasogastric intubation (upper airway surgery, bleeding disorders)
- Expected difficulties in obtaining reliable pressure measurements, such as known airleak into pleural space or diaphragmatic herniation
Sites / Locations
- VU University medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Standard of care
Titration of support level
Outcomes
Primary Outcome Measures
Adequate diaphragm loading
Percentage of time that the diaphragm operates within physiological levels of activity (Transdiaphragmatic pressure per breath between 3-12 cmH2O).
Secondary Outcome Measures
Pressure-time product of diaphragm activity
Average pressure-time product of the diaphragm calculated as the time-integral of transdiaphragmatic pressure, reported and compared between intervention and control
Work of breathing
Average work per breath and work per minute, calculated as the volume-pressure integral of esophageal pressure, reported and compared between intervention and control
Markers for lung-protective ventilation
Average transpulmonary pressure, tidal volumes, plateau airway pressures, markers for systemic inflammation and mechanical power reported and compared between intervention and control
Patient ventilator interaction
Average percentage of asynchrony events, calculated as number of asynchronies / total breathing cycles * 100%, reported and compared between intervention and control
Full Information
NCT ID
NCT03527797
First Posted
April 24, 2018
Last Updated
March 17, 2021
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT03527797
Brief Title
Diaphragm Protective Ventilation in the Intensive Care Unit
Acronym
DiaPro
Official Title
Diaphragm-protective Mechanical Ventilation in Critically Ill Patients: A Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
July 16, 2020 (Actual)
Study Completion Date
October 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
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
Due to an accident, pneumonia or surgery, patients can have severe shortness of breath or lung damage to such an extent that it compromises vital functions. At such times, mechanical ventilation can be lifesaving. The ventilator temporarily takes over the function of the respiratory muscles to ensure adequate uptake of oxygen and removal of carbon dioxide. Mechanical ventilation can usually be stopped quickly after the initial disease has been treated. Unfortunately, in up to 25-40% of ventilated patients it takes several days to weeks before mechanical ventilation can be discontinued, even after treatment of the initial disease. This phenomenon is termed weaning failure. Weakness of the respiratory muscles, such as the diaphragm, is one of the leading causes of weaning failure.
Like other skeletal muscles, the diaphragm can become weakened if it is used too little. This happens often during mechanical ventilation because of excessive assistance provided by the ventilator or use of sedative medication. Excessive activity of the diaphragm can also lead to damage and weakness, just like in other muscles that have to perform excessive amounts for a prolonged period of time. Additionally, excessive work by the diaphragm might have a direct damaging effect on the lungs, which leads to a vicious cycle. As such, it is very important to find a balance between resting the diaphragm (which may lead to weakness) and placing excessive work on the diaphragm (which can damage the diaphragm and possibly the lungs).
In this study, the investigators want to test whether insufficient activity and excessive activity of the diaphragm during mechanical ventilation can be prevented or reduced. The investigators plan to measure the diaphragm activity in 40 participants on mechanical ventilation. Participants will be randomly assigned to the intervention group or the control group. In the intervention group, ventilator support levels will be adjusted according to the observed diaphragm activity, in an attempt to ensure adequate diaphragm activity. The control group receives usual care. The hypothesis is that adjusting the level of support provided by the ventilator is a feasible method to improve the time that the diaphragm operates within acceptable levels of activity over a 24 hour period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Muscle Weakness, Muscle Damage, Respiration, Artificial, Respiratory, Diaphragm
Keywords
Critical illness associated diaphragm weakness, Mechanical ventilation, Critical illness, Respiratory muscle dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Titration of support level
Intervention Type
Other
Intervention Name(s)
Titration of support level
Intervention Description
Increasing support in case diaphragm activity is too high. Decreasing support in case diaphragm activity is too low.
Primary Outcome Measure Information:
Title
Adequate diaphragm loading
Description
Percentage of time that the diaphragm operates within physiological levels of activity (Transdiaphragmatic pressure per breath between 3-12 cmH2O).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pressure-time product of diaphragm activity
Description
Average pressure-time product of the diaphragm calculated as the time-integral of transdiaphragmatic pressure, reported and compared between intervention and control
Time Frame
24 hours
Title
Work of breathing
Description
Average work per breath and work per minute, calculated as the volume-pressure integral of esophageal pressure, reported and compared between intervention and control
Time Frame
24 hours
Title
Markers for lung-protective ventilation
Description
Average transpulmonary pressure, tidal volumes, plateau airway pressures, markers for systemic inflammation and mechanical power reported and compared between intervention and control
Time Frame
24 hours
Title
Patient ventilator interaction
Description
Average percentage of asynchrony events, calculated as number of asynchronies / total breathing cycles * 100%, reported and compared between intervention and control
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent
Receives partially supported mechanical ventilation
Estimated duration of mechanical ventilation after inclusion of at least 24 hours, as estimated by the attending physician
Exclusion Criteria:
Known neuromuscular disease
Contra-indications for nasogastric intubation (upper airway surgery, bleeding disorders)
Expected difficulties in obtaining reliable pressure measurements, such as known airleak into pleural space or diaphragmatic herniation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo M Heunks, MD, PhD
Organizational Affiliation
Professor of Experimental Intensive Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angélique Spoelstra - de Man, MD, PhD
Organizational Affiliation
Intensivist
Official's Role
Study Chair
Facility Information:
Facility Name
VU University medical center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Diaphragm Protective Ventilation in the Intensive Care Unit
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