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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647361
• Other study ID #: KEK BE 217-06
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2008
• Last updated: July 18, 2011
• Start date: March 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

• excessive activation of inspiratory and / or expiratory muscles as assessed by observation of the patient

4. Presence of a pulmonary artery catheter and an arterial pressure line

5. Subject itself or its next of kin has given written informed consent

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

11. Any mechanical cardiac assist device (including intraaortic balloon pump)

12. Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing

13. The patient needs to be ventilated with a mode of MV controlling for tidal volume or for airway pressure as per attending physician.

14. Severe hemodynamic instability as judged by the attending physician

15. Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.

16. a fraction of inspired oxygen (FiO2) of > 0.8

17. The patient currently participates in another interventional clinical trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine, University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac stroke volume index.		end of experimental periods	No
Secondary	Global delivery of oxygen		end of experimental period	No