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Completed

NCT Number: NCT03539640

Effect PEEP on Diaphragm

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.

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Key information

Conditions

Diaphragm Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEEP: 5 cmH2O

Other

During second part of the study (MRI)

PEEP: 10 cmH2O

Other

During second part of the study (MRI)

PEEP: 15 cmH2O

Other

During second part of the study (MRI)

Primary outcomes

  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 outcomes

  1. Difference between MRI and ultrasound

    Time frame: 2 hours

    The difference between diaphragm parameters obtained by ultrasound and parameters obtained by MRI

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
May 29, 2018
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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