Effect PEEP on Diaphragm

NCT03539640 | Completed

• 1 other identifier: NL63905.029.17
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragm Disease

Keywords

PEEP; Diaphragm

Outcome Measures

Primary Outcomes (4)

• Changes in diaphragm's position

  Changes in the position of the diaphragm during different PEEP levels, as measured with both ultrasound and MRI

  2 hours

• Changes in diaphragm's shape and length

  Changes of the diaphragm's shape and length during different PEEP levels, as measured with MRI

  2 hours

• Changes in diaphragm's efficiency

  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

  2 hours

• Change in twitch transdiaphragmatic pressures

  Twitch transdiaphragmatic pressures during different PEEP levels, as measured with magnetic stimulation of the phrenic nerves.

  2 hours

Secondary Outcomes (1)

• Difference between MRI and ultrasound

  2 hours

Other Outcomes (2)

• Expiratory abdominal muscle activity

  2 hours

• Flow

  2 hours

Study Arms (3)

PEEP level of 5 cmH2O

ACTIVE COMPARATOR

During second part of the study (MRI) Diaphragm position

Other: PEEP: 5 cmH2O

PEEP level of 10 cmH2O

ACTIVE COMPARATOR

During second part of the study (MRI) Diaphragm position

Other: PEEP: 10 cmH2O

PEEP level of 15 cmH2O

ACTIVE COMPARATOR

During second part of the study (MRI) Diaphragm position

Other: PEEP: 15 cmH2O

Interventions

PEEP: 5 cmH2O OTHER

During second part of the study (MRI)

PEEP level of 5 cmH2O

PEEP: 10 cmH2O OTHER

During second part of the study (MRI)

PEEP level of 10 cmH2O

PEEP: 15 cmH2O OTHER

During second part of the study (MRI)

PEEP level of 15 cmH2O

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age ≥ 18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Study Officials

• Leo Heunks, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 29, 2018
• Study Start: April 13, 2018
• Primary Completion: December 12, 2018
• Study Completion: May 1, 2019
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

NL (1)