Electrical Activity of the Diaphragm During the Weaning Period

July 31, 2013 updated by: Marco Ranieri, University of Turin, Italy

Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period

The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Torino
      • Co.so Bramante 88, Torino, Italy, 10126
        • Marco Ranieri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients older than 18 years and mechanically ventilated for >= 48 h.
  • In the resolving stage of the disease which brought to mechanical ventilation.
  • Pao2/Fio2 ratio >150 on positive end-expiratory pressure (PEEP) <=8 cm H2O.
  • Sedation discontinued for a minimum of 24 hrs
  • Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.
  • Patient fully alert and cooperative.
  • Intact respiratory drive evaluated with Glasgow Coma Scale >=10.

Exclusion Criteria:

  • The attending physician refuses to allow enrolment
  • The patient refuses informed consent
  • Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine > 5 mcg/kg/min or norepinephrine > 0.1 mcg/kg/min to maintain systolic arterial blood pressure > 90 mmHg)
  • No collaborative Patient
  • Coagulation or platelets disorders
  • neuromuscular disease
  • phrenic nerve damage/diaphragm paralysis
  • contraindication to exchange naso-gastric tube
  • History of heart or lung transplantation
  • Presence or suspicion of a central nervous system disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EADIWEANING
Patients mechanically ventilated for more than 48 hours during the weaning process.
Device: Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
Nava is a new ventilatory mode which delivers pressure in proportion of the the Electrical activity of the diaphragm (EAdi), a reflection of the neural respiratory output. EAdi will be obtained through a nasogastric tube with a multiple array of electrodes placed at its distal end. Correct positioning of the EAdi catheter is assured by means of a specific function of the ventilator (''EAdi catheter positioning''). The EAdi signal is processed according to the American Thoracic Society (ATS) recommendations and filtered by algorithms designed to provide the highest possible signal-to-noise ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electrical activity of the diaphragm as a predictor of weaning outcome
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of electrical activity of the diaphragm as a predictor versus other predictors
Time Frame: 48 hours
48 hours
Evaluation of respiratory parameters during the weaning process
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EADIWEANIG299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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