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Clinical Trials/NCT03539640
NCT03539640
Completed
Not Applicable

The Effects of Positive End-expiratory Pressure on the Position, Length and Contractibility of the Diaphragm.

Amsterdam UMC, location VUmc1 site in 1 country22 target enrollmentApril 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragm Disease
Sponsor
Amsterdam UMC, location VUmc
Enrollment
22
Locations
1
Primary Endpoint
Changes in diaphragm's position
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2018
End Date
May 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Prof.dr. L.M.A. Heunks

MD, PhD

Amsterdam UMC, location VUmc

Eligibility 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.

Outcomes

Primary Outcomes

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

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

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

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 Outcomes

  • Difference between MRI and ultrasound(2 hours)

Study Sites (1)

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