Diaphragmatic Activity During Weaning With NAVA, a Pilot Study (NAVA: Neurally Adjusted Ventilatory Assist) (NAVA)

Diaphragmatic Activity During a Postoperative Rapid Weaning Protocol With Neurally Adjusted Ventilatory Assist in Healthy Lung Patients, a Pilot Study.

The purpose of this study is to describe the diaphragm electromyographic activity (Edi) in healthy lung patients due to obtain a reference to guide the weaning in those patients

Study Overview

• Status: Completed
• Conditions: Postoperative Patients
• Intervention / Treatment: Procedure: weaning protocol

Detailed Description

We obtained the Edi recording data at each NAVA level during the weaning in NAVA group, and we compared the respiratory parameters between the PSV and NAVA groups

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who were scheduled for elective major surgery in which admission to the CCU (critical care unit) for postoperative care and short-term mechanical ventilation with rapid weaning were anticipated.

Exclusion Criteria:

• Preoperative altered central nervous system, neuromuscular or lung disease and ASA (american society of anesthesiologists) classification group IV or NYHA (New York heart association) class IV in the case of cardiac patients. At the CCU, before randomisation, we also excluded patients requiring reoperation, and those who exhibited significant postsurgical bleeding, the development of myocardial infarction, and hemodynamic instability.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NAVA group with a specific catheter; The patients were allocated in the NAVA weaning protocol group	Procedure: weaning protocol; The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
Other: PSV group without a specific catheter; The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group	Procedure: weaning protocol; The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diaphragmatic electromyographic activity description	1 hour

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Investigators: Principal Investigator: Mar Garzando Civera, M.D., Ph.D., Fundación para la investigación del Hospital Clínico Universitario de Valencia

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 4, 2016
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Weaning; NAVA: neurally adjusted ventilatory assist; Diaphragm electromyographic activity
• Other Study ID Numbers: dawNAVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Shared data will be anonymous

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No