Diaphragm-protective mechanical ventilation in critically ill patients: A proof of concept study.
Completed
- Conditions
- respiratory muscle weaknessventilator-induced diaphragm dysfunction1002830210013369
- Registration Number
- NL-OMON44635
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
-Informed consent
-Age >18 years
-Supportive ventilation mode
-Expected duration of mechanical ventilation at least 24 hours at moment of inclusion
Exclusion Criteria
-Current neuromuscular disease
-Contraindication for nasogastric intubation, including recent upper airway surgery and severe bleeding disorders
-Expected difficulties in acquiring reliable pressure measurements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint of the study is the time that diaphragm activity was within<br /><br>physiological range during the study period. Diaphragm activity will be<br /><br>continuously measured as the trandiaphragmatic pressure (Pdi), using the<br /><br>formula below:<br /><br><br /><br>(1) Transdiaphragmatic pressure (Pdi) = Gastic pressure (Pga) - Esophageal<br /><br>pressure (Pes)<br /><br><br /><br>Pdi will be analysed on a breath-by-breath basis after conclusion of the study<br /><br>period. Every breath within the range of 3-12 cmH2O will be considered as<br /><br>physiological. The percentage of physiological breaths will be calculated as:<br /><br><br /><br>(2) Percentage of diaphragm-protective breaths = ( number of physiological<br /><br>breaths) / (total number of breaths) *100%.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary outcome parameters include:<br /><br>-Percentage of time that the pressure-time product of the diaphragm (PTPdi) was<br /><br>within physiological range during the study period<br /><br>-Effect of the intervention on various clinical parameters including results of<br /><br>blood gas analysis, inflammatory parameters and patient comfort<br /><br>- Various feasibility parameters, such as the percentage of patients admitted<br /><br>during the study period which were eligeble for inclusion, the number of<br /><br>patients that were prematurely withdrawn from the study, reason of early<br /><br>withdrawal and number of adjustments made to the ventilator settings during the<br /><br>study period. </p><br>