Electrical Activity of the Diaphragm During the Weaning Period

Respiratory Insufficiency Clinical Trial

Official title:

Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411722
• Other study ID #: EADIWEANIG299
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2011
• Last updated: July 31, 2013
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome

Description:

Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients older than 18 years and mechanically ventilated for >= 48 h.

• In the resolving stage of the disease which brought to mechanical ventilation.

• Pao2/Fio2 ratio >150 on positive end-expiratory pressure (PEEP) <=8 cm H2O.

• Sedation discontinued for a minimum of 24 hrs

• Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.

• Patient fully alert and cooperative.

• Intact respiratory drive evaluated with Glasgow Coma Scale >=10.

Exclusion Criteria:

• The attending physician refuses to allow enrolment

• The patient refuses informed consent

• Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine > 5 mcg/kg/min or norepinephrine > 0.1 mcg/kg/min to maintain systolic arterial blood pressure > 90 mmHg)

• No collaborative Patient

• Coagulation or platelets disorders

• neuromuscular disease

• phrenic nerve damage/diaphragm paralysis

• contraindication to exchange naso-gastric tube

• History of heart or lung transplantation

• Presence or suspicion of a central nervous system disorder

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
Nava is a new ventilatory mode which delivers pressure in proportion of the the Electrical activity of the diaphragm (EAdi), a reflection of the neural respiratory output. EAdi will be obtained through a nasogastric tube with a multiple array of electrodes placed at its distal end. Correct positioning of the EAdi catheter is assured by means of a specific function of the ventilator (''EAdi catheter positioning''). The EAdi signal is processed according to the American Thoracic Society (ATS) recommendations and filtered by algorithms designed to provide the highest possible signal-to-noise ratio

Locations

Country	Name	City	State
Italy	Marco Ranieri	Co.so Bramante 88	Torino

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical activity of the diaphragm as a predictor of weaning outcome		48 hours	No
Secondary	Comparison of electrical activity of the diaphragm as a predictor versus other predictors		48 hours	No
Secondary	Evaluation of respiratory parameters during the weaning process		48 hours	No