NCT03027713

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

4 years

First QC Date

September 4, 2016

Last Update Submit

January 19, 2017

Conditions

Postoperative Patients

Keywords

NAVA: neurally adjusted ventilatory assistDiaphragm electromyographic activityWeaning

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic electromyographic activity description

    1 hour

Study Arms (2)

NAVA group with a specific catheter

OTHER

The patients were allocated in the NAVA weaning protocol group

Procedure: weaning protocol

PSV group without a specific catheter

OTHER

The patients were allocated in the PSV (pressure-support ventilation) weaning protocol group

Procedure: weaning protocol

Interventions

weaning protocolPROCEDURE

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

NAVA group with a specific catheterPSV group without a specific catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mar Garzando Civera, M.D., Ph.D.

    Fundación para la investigación del Hospital Clínico Universitario de Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 4, 2016

First Posted

January 23, 2017

Study Start

June 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

Shared data will be anonymous