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

NCT01248845 | Terminated

• 1 other identifier: EMG_titr
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

Mechanical ventilation; Electrical diaphragmatic activity

Outcome Measures

Primary Outcomes (1)

• 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 (1)

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

Interventions

Titration of various level of assistance OTHER

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Philippe Jolliet: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

CHUV, University hospital of lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Philippe Jolliet, Professor

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Main investigator

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: November 25, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CH (1)