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Diaphragm-protective mechanical ventilation in critically ill patients: A proof of concept study.

Diaphragm-protective mechanical ventilation in critically ill patients: A proof of concept study. - DiaPro

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44635
Enrollment
40
Registered
2017-11-14
Start date
2018-04-25
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory muscle weakness ventilator-induced diaphragm dysfunction

Interventions

In both control and intervention group diaphragm activity will be monitored continuously using esophageal and gastric pressure catheters. In the intervention group, ventilator settings will be adjus

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoint of the study is the time that diaphragm activity was within physiological range during the study period. Diaphragm activity will be continuously measured as the trandiaphragmatic pressure (Pdi), using the formula below: (1) Transdiaphragmatic pressure (Pdi) = Gastic pressure (Pga) - Esophageal pressure (Pes) Pdi will be analysed on a breath-by-breath basis after conclusion of the study period. Every breath within the range of 3-12 cmH2O will be considered as physiological. The percentage of physiological breaths will be calculated as: (2) Percentage of diaphragm-protective breaths = ( number of physiological breaths) / (total number of breaths) *100%.

Secondary

MeasureTime frame
Secundary outcome parameters include: -Percentage of time that the pressure-time product of the diaphragm (PTPdi) was within physiological range during the study period -Effect of the intervention on various clinical parameters including results of blood gas analysis, inflammatory parameters and patient comfort - Various feasibility parameters, such as the percentage of patients admitted during the study period which were eligeble for inclusion, the number of patients that were prematurely withdrawn from the study, reason of early withdrawal and number of adjustments made to the ventilator settings during the study period.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)