Diaphragm Disease Clinical Trial
Official title:
The Effects of Positive End-expiratory Pressure on the Position, Length and Contractibility of the Diaphragm.
Verified date | May 2020 |
Source | VU University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 1, 2019 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | VU Medical Center | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Expiratory abdominal muscle activity | Expiratory abdominal muscle activity during different levels of PEEP measured with surface EMG electrodes | 2 hours | |
Other | Flow | Flow during different levels of PEEP measured by the non-invasive ventilator | 2 hours | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change in twitch transdiaphragmatic pressures | Twitch transdiaphragmatic pressures during different PEEP levels, as measured with magnetic stimulation of the phrenic nerves. | 2 hours | |
Secondary | Difference between MRI and ultrasound | The difference between diaphragm parameters obtained by ultrasound and parameters obtained by MRI | 2 hours |
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