Electrical Activity of the Diaphragm During the Weaning Period

University of Turin

Status and phase: Completed; Phase 2

Conditions: Respiratory Insufficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01411722

EADIWEANIG299

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

EADIWEANING

Other group

Description:

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

Treatment:

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