Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance - Full Text View

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:

MedlinePlus related topics: Respiratory Failure

U.S. FDA Resources

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:

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

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 May 19, 2013