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

NCT00647361 | Completed Phase 1

• 1 other identifier: KEK BE 217-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Cardiac Failure

Keywords

respiratory insufficiency; respiration; ventilators; diaphragm; electromyography; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Cardiac stroke volume index.

  end of experimental periods

Secondary Outcomes (1)

• Global delivery of oxygen

  end of experimental period

Study Arms (1)

NAVA

EXPERIMENTAL

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

Interventions

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)

NAVA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Intensive Care Medicine, University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

  PMID: 10581089 BACKGROUND

• Berger D, Bloechlinger S, Takala J, Sinderby C, Brander L. Heart-lung interactions during neurally adjusted ventilatory assist. Crit Care. 2014 Sep 12;18(5):499. doi: 10.1186/s13054-014-0499-8.

  PMID: 25212533 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Heart Failure; Respiratory Aspiration

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lukas Brander, MD

  Department of Intensive Care Medicine, University Hospital - Inselspital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 31, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

CH (1)