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

Postoperative Patients Clinical Trial

— NAVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027713
• Other study ID #: dawNAVA
• Status: Completed
• Phase: N/A
• First received: September 4, 2016
• Last updated: January 19, 2017
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Patients

Intervention

Procedure:
• weaning protocol
The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic electromyographic activity description		1 hour