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

This study has been terminated.
(Difficulties to enroll patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248845
First Posted: November 25, 2010
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Prof. Philippe Jolliet, University of Lausanne Hospitals
  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: None (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

Further study details as provided by Prof. Philippe Jolliet, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance
    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.
    To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.


Enrollment: 2
Study Start Date: August 2010
Study Completion Date: June 2016
Primary Completion Date: June 2016 (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

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248845


Locations
Switzerland
CHUV, University hospital of lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Prof. Philippe Jolliet
University of Lausanne Hospitals
Investigators
Principal Investigator: Philippe Jolliet, Professor University of Lausanne Hospitals
  More Information

Responsible Party: Prof. Philippe Jolliet, Main investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01248845     History of Changes
Other Study ID Numbers: EMG_titr
First Submitted: August 20, 2010
First Posted: November 25, 2010
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Prof. Philippe Jolliet, University of Lausanne Hospitals:
Mechanical ventilation
Electrical diaphragmatic activity

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