An observational study in Mechanical Ventilation Complication, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational
The transition from controlled mechanical ventilation to assisted ventilation is one of the most complex and compromised phases of the ventilatory management during mechanical ventilation, affected by factors such as:
Current monitoring of assisted ventilation is complex and not well resolved by most conventional ventilators. Asynchronies are difficult to monitor with the pressure or flow/time curves present in conventional ventilators requiring an advanced level of expertise. Measurements of the patient's muscular effort and therefore of transpulmonary pressure, requires the use of esophageal manometry with cumbersome handling and interpretation.
NAVA (Neurally Adjusted Ventilatory Assist) is a ventilator mode that uses electrical activity of the diaphragm (EAdi), monitored via a modified nasogastric feeding catheter, to control and assist the respiratory cycle by the ventilator. Recently, a "hybrid" mode between the conventional pressure support assisted mode (PSV) and NAVA called Neural-Pressure Support Ventilation (N-PSV) has been developed. This mode uses a neural trigger based on the EAdi to match the patient's and ventilator's in- and expiratory time, but unlike NAVA, assisting in the same way as in pressure support. In addition the EAdi allows to assess the extent to which the patient's muscle strength contributes to the patient-ventilator breath (PVBC), and it has recently been suggested that on the basis of PVBC it may also be possible to directly estimate the patient's transpulmonary pressure (PL).
Hypothesis:
Consenting participants will be simultaneously monitored with a 8French EAdi catheter (to measure the electrical activity of the diaphragm) and a 15French nasogastric catheter with an oesophageal balloon to measure oesophageal manometry during the 120 min of the total study period.
After confirming correct positioning and measurement of both catheters participants will be submitted to the following protocol:
Baseline ventilation in pressure support ventilation during 30 min Baseline ventilation in neural-pressure support ventilation during 30 min Under-assistance in neural pressure support ventilation reducing the baseline level of pressure support by 50% (with a minimum of 5 cmH2O) during 30 min Over-assistance in neural pressure support ventilation by increasing the baseline level of pressure by 50% during 30 min.
The sequence of the last two steps will be randomly determined. After completing the protocol the EAdi catheter will be removed.
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients under assisted mechanical ventilation with spontaneous breathing and adequate respiratory drive.
Clinical stability, defined as:
Exclusion Criteria:
Patients under assisted mechanical ventilation monitored with esophageal manometry and electrical activity of the diaphragm
Device: Esophageal manometry and monitoring of electrical activity of the diaphragm
Esophageal manometry and monitoring of electrical activity of the diaphragm
Number of asynchronies
Asynchrony index
Time frame: 60 minutes
Estimation of transpulmonary pressure
Evaluation of a new method for measuring transpulmonary pressure based on the electrical activity of the diaphragm
Time frame: 90 minutes
Plan to share: No
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa