Back to resultsComparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance
Primary Purpose
Respiratory Failure
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Titration of various level of assistance
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Failure focused on measuring Mechanical ventilation, Electrical diaphragmatic activity
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.
Sites / Locations
- CHUV, University hospital of lausanne
Outcomes
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.
Full Information
NCT ID
NCT01248845
First Posted
August 20, 2010
Last Updated
May 4, 2017
Sponsor
Prof. Philippe Jolliet
Collaborators
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT01248845
Brief Title
Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulties to enroll patients
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Philippe Jolliet
Collaborators
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Mechanical ventilation, Electrical diaphragmatic activity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Titration of various level of assistance
Intervention 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.
Primary Outcome Measure Information:
Title
Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance
Description
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 Measure Information:
Title
Compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.
Description
To compare a non invasive technique of diaphragmatic electrical activity recording under various levels of assistance with the invasive reference technique.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Jolliet, Professor
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV, University hospital of lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
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Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance
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