Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance

This study is currently recruiting participants.
Verified May 2013 by University of Lausanne Hospitals
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01248845
First received: August 20, 2010
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.


Condition Intervention
Respiratory Failure
Other: Titration of various level of assistance

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance in Pressure Support and in Neurally Adjusted Ventilatory Assist

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance [ Designated as safety issue: No ]
    To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in Pressure and in Neurally adjusted ventilatory assist in intubated spontaneously breathing patients


Secondary Outcome Measures:
  • Compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique. [ Designated as safety issue: No ]
    To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Titration of various level of assistance
    Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
Detailed Description:

Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.

Aims of the study:

  1. To study the electrical diaphragmatic signal variations and the ventilatory profile variations under various level of assistance (delivered by the ventilator) in PS and in NAVA in intubated spontaneously breathing patients
  2. To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients admitted to the ICU, intubated for acute respiratory failure, and ventilated in PS mode will be eligible for inclusion in the study.

Exclusion Criteria:

  • Severe hypoxemia requiring an FIO2 > 0.5
  • hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-)
  • oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery;
  • active upper gastro-intestinal bleeding;
  • known coagulation disorder;
  • any other contraindication to the insertion of a naso-gastric tube;
  • poor short term prognosis (death expected within the next seven days)
  • age < 18 years old.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248845

Contacts
Contact: Lise Piquilloud lise.piquilloud@chuv.ch

Locations
Switzerland
CHUV, University hospital of lausanne Recruiting
Lausanne, Switzerland, 1011
Contact: Lise Piquilloud    +795567642    lise.piquilloud@chuv.ch   
Contact: Philippe Jolliet, Prof       philippe.jolliet@chuv.ch   
Sub-Investigator: Lise Piquilloud         
Principal Investigator: Philippe Jolliet         
Sub-Investigator: Jean-Pierre Revelly, MD         
Sponsors and Collaborators
Prof. Philippe Jolliet
University of Lausanne Hospitals
Investigators
Principal Investigator: Philippe Jolliet, Professor University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01248845     History of Changes
Other Study ID Numbers: EMG_titr
Study First Received: August 20, 2010
Last Updated: May 15, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Laws and standards

Keywords provided by University of Lausanne Hospitals:
Mechanical ventilation
Electrical diaphragmatic activity

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014