Electrical Activity of the Diaphragm During the Weaning Period

NCT ID: NCT01411722

Last Updated: 2013-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-06-30

Brief 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

Detailed 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.

Conditions

Respiratory Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EADIWEANING

Patients mechanically ventilated for more than 48 hours during the weaning process.

Group Type: OTHER

Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Marco Ranieri

MD Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Ranieri

Co.so Bramante 88, Torino, Italy

Countries

Italy

Other Identifiers

EADIWEANIG299

Identifier Type: -

Identifier Source: org_study_id