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Effect PEEP on Diaphragm

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ClinicalTrials.gov Identifier: NCT03539640
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Prof.dr. L.M.A. Heunks, VU University Medical Center

Study Description
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Brief Summary:
This study evaluates the effect of positive end-expiratory pressure on the position, length and function of the diaphragm. During the first part of the study, physiological measurements of the diaphragm will be performed while participants receive non-invasive ventilation at different PEEP levels. During the second part of the study, MRI measurements of the diaphragm will be performed during a change in PEEP level.

Condition or disease Intervention/treatment Phase
Diaphragm Disease Other: PEEP: 5 cmH2O Other: PEEP: 10 cmH2O Other: PEEP: 15 cmH2O Not Applicable

Detailed Description:

In almost all mechanically ventilated patients, positive end-expiratory pressure (PEEP) is used. Its function is to prevent alveolar collapse and to maintain oxygenation. However, it has recently been found that PEEP may contribute to diaphragm weakness, which is an important problem in the intensive care unit (ICU). This study showed that mechanical ventilation with PEEP resulted in a caudal displacement of the diaphragm, since PEEP increases the end-expiratory volume. Furthermore, their study in rats showed that this displacement resulted in a reduced fiber length and sarcomere length on the short term.

After rats were ventilated with PEEP for 18 hours, it was found that adaptation of the diaphragm occurred; i.e. the number of sarcomeres were decreased. It is hypothesized that this adaptation may also occur in mechanically ventilated patients. This could lead to problems in weaning a patient off the ventilator, as PEEP is abruptly removed during a spontaneous breathing trial (SBT). This leads to a reduction in end-expiratory volume which would mean that the newly-adapted diaphragm fibers are being stretched. These stretched muscle fibers are not working at their optimal length of the force-length relation, thereby contributing to diaphragm weakness.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All participants will receive the same protocol with different levels of PEEP ventilation during the first part of the study (physiological part), so the interventional study model for this part is single group. During the second part (MRI), participants are randomized for one of the three available PEEP levels (5, 10 or 15 cmH2O), so the study model for this part is parallel.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor of the MRI measurements will analyze the MRI data in a blinded fashion. The rest of the outcomes will not be analyzed in a blinded fashion.
Primary Purpose: Basic Science
Official Title: The Effects of Positive End-expiratory Pressure on the Position, Length and Contractibility of the Diaphragm.
Actual Study Start Date : April 13, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : May 1, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PEEP level of 5 cmH2O
During second part of the study (MRI) Diaphragm position
 Other: PEEP: 5 cmH2O
During second part of the study (MRI)
Active Comparator: PEEP level of 10 cmH2O
During second part of the study (MRI) Diaphragm position
 Other: PEEP: 10 cmH2O
During second part of the study (MRI)
Active Comparator: PEEP level of 15 cmH2O
During second part of the study (MRI) Diaphragm position
 Other: PEEP: 15 cmH2O
During second part of the study (MRI)


Outcome Measures
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Primary Outcome Measures :
  1. Changes in diaphragm's position [ Time Frame: 2 hours ]
    Changes in the position of the diaphragm during different PEEP levels, as measured with both ultrasound and MRI

  2. Changes in diaphragm's shape and length [ Time Frame: 2 hours ]
    Changes of the diaphragm's shape and length during different PEEP levels, as measured with MRI

  3. Changes in diaphragm's efficiency [ Time Frame: 2 hours ]
    Changes in the neuro-mechanical efficiency of the diaphragm (ratio between pressure and electrical muscle activity) during different PEEP levels, as measured with a nasogastric catheter

  4. Change in twitch transdiaphragmatic pressures [ Time Frame: 2 hours ]
    Twitch transdiaphragmatic pressures during different PEEP levels, as measured with magnetic stimulation of the phrenic nerves.


Secondary Outcome Measures :
  1. Difference between MRI and ultrasound [ Time Frame: 2 hours ]
    The difference between diaphragm parameters obtained by ultrasound and parameters obtained by MRI


Other Outcome Measures:
  1. Expiratory abdominal muscle activity [ Time Frame: 2 hours ]
    Expiratory abdominal muscle activity during different levels of PEEP measured with surface EMG electrodes

  2. Flow [ Time Frame: 2 hours ]
    Flow during different levels of PEEP measured by the non-invasive ventilator


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 years

Exclusion Criteria:

  • Symptoms relating to respiratory or cardiovascular disease
  • History of pneumothorax or family history of primary pneumothorax
  • Obesity (defined as BMI > 30kg/m²)
  • Known pregnancy
  • Contraindications for the placement of a nasogastric tube (upper airway/esophageal/gastric/mouth or face pathology (e.g. recent surgery, esophageal varices, diaphragmatic hernia), nasal bleeding within the last 2 weeks or use of anticoagulants)
  • Contraindications for MRI (electrical/metallic implants, claustrophobia or history in metalworking)
  • Subjects who are employed at the department of intensive care adults, directly involved in the study and/or family from staff of the ICU.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539640


Locations
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Netherlands
VU Medical Center
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
Investigators
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Principal Investigator: Leo Heunks, MD, PhD VU University Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Prof.dr. L.M.A. Heunks, MD, PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03539640    
Other Study ID Numbers: NL63905.029.17
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.dr. L.M.A. Heunks, VU University Medical Center:
PEEP
Diaphragm