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Clinical Trials/NCT01248845
NCT01248845
Terminated
Not Applicable

Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance in Pressure Support and in Neurally Adjusted Ventilatory Assist

Prof. Philippe Jolliet1 site in 1 country2 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Prof. Philippe Jolliet
Enrollment
2
Locations
1
Primary Endpoint
Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
June 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Prof. Philippe Jolliet
Responsible Party
Sponsor Investigator
Principal Investigator

Prof. Philippe Jolliet

Main investigator

University of Lausanne Hospitals

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.

Study Sites (1)

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