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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01248845
• Other study ID #: EMG_titr
• Status: Terminated
• Phase: N/A
• First received: August 20, 2010
• Last updated: May 4, 2017
• Start date: August 2010
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Switzerland	CHUV, University hospital of lausanne	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Philippe Jolliet	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.