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Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance

Short Term Effects of Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation on Cardiac Performance

NCT00647361•Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

Summary

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of NAVA on cardiac performance in critically ill, mechanically ventilated patients.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients aged 18 - 85 years (extremes included)
•2. Mechanical ventilation (tracheally intubated or tracheotomized)
•3. Relevant interaction between the ventilator and the cardiac performance defined as an inspiratory deflection in central venous pressure or pulmonary diastolic pressure of ≥ 5 mmHg
•1. in 10 patients with impaired cardiac performance defined as either
•* a left ventricular ejection fraction of \< 40% and/or
•* treatment with dobutamine ≥2μg/kg/min, or adrenaline ≥ 3μg/kg/min and/or
•* a cardiac index of ≤ 2.2 L•min-1•m2 and/or
•* a pulmonary artery occlusion pressure (PAOP) ≥ 18 mmHg
•2. in 10 patients with a history of chronic obstructive pulmonary disease (COPD) and delayed triggering-ON / cycling-OFF and/or evidence for wasted inspiratory efforts as evidenced by:
•* limitation of expiratory air flow and intrinsic PEEP as assessed by observation of the expiratory air flow curve and measurement of the airway pressure during an expiratory hold maneuver and/or
+3 more criteria

Exclusion Criteria

•1. Patient is less than 18 years or more than 80 years of age
•2. The attending physician refuses to allow enrollment
•3. The patient refuses informed consent
•4. Next of kin is unavailable or refuses informed consent
•5. Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age. The patient will not be enrolled in the study if the test result is positive.
•6. Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
•7. Presence or suspicion of diaphragm injury
•8. Hemophilia or other severe bleeding disorder
•9. Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
•10. History of heart and/or lung transplantation
+7 more criteria

Locations (1)

Department of Intensive Care Medicine, University Hospital

Bern, Canton of Bern, Switzerland

Key Dates

Start Date

March 1, 2008

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

July 19, 2011

Enrollment

ACTUAL participants

Conditions

Respiratory FailureCardiac Failure

Interventions

Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).

DEVICE

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

NCT07186933

Postoperative Pulmonary AtelectasisPostoperative Pulmonary Complications+8 more

View study

RECRUITINGNA

Non-Invasive Ventilation Versus High-flow Nasal Oxygen in Intensive Care Units

NCT05686850

Post Extubation Respiratory Failure

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance

Inclusion Criteria

Exclusion Criteria

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

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Global Physiotherapy in ICU Patients With High Risk Extubation Failure

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Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure