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OpenTrials
Completed

NCT Number: NCT00647361

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Intensive Care Medicine, University Hospital

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients aged 18 - 85 years (extremes included)
  • Mechanical ventilation (tracheally intubated or tracheotomized)
  • 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
  • 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
  • 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
  • excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient
  • Presence of a pulmonary artery catheter and an arterial pressure line
  • Subject itself or its next of kin has given written informed consent

Exclusion criteria

  • Patient is less than 18 years or more than 80 years of age
  • The attending physician refuses to allow enrollment
  • The patient refuses informed consent
  • Next of kin is unavailable or refuses informed consent
  • 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.
  • 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
  • Presence or suspicion of diaphragm injury
  • Hemophilia or other severe bleeding disorder
  • Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
  • History of heart and/or lung transplantation
  • Any mechanical cardiac assist device (including intraaortic balloon pump)
  • Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
  • The patient needs to be ventilated with a mode of MV controlling for tidal volume or for airway pressure as per attending physician.
  • Severe hemodynamic instability as judged by the attending physician
  • Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
  • a fraction of inspired oxygen (FiO2) of > 0.8
  • The patient currently participates in another interventional clinical trial

Treatment and study plan

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

Device

Neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV)

Primary outcomes

  1. Cardiac stroke volume index.

    Time frame: end of experimental periods

Secondary outcomes

  1. Global delivery of oxygen

    Time frame: end of experimental period

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2008
Registry last updated
Jul 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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