Electrical Activity of the Diaphragm During the Weaning Period

NCT01411722 | Completed Phase 2

• 1 other identifier: EADIWEANIG299
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Insufficiency

Keywords

Electrical Activity of Diaphragm; Weaning outcome; NAVA

Outcome Measures

Primary Outcomes (1)

• Electrical activity of the diaphragm as a predictor of weaning outcome

  48 hours

Secondary Outcomes (2)

• Comparison of electrical activity of the diaphragm as a predictor versus other predictors

  48 hours

• Evaluation of respiratory parameters during the weaning process

  48 hours

Study Arms (1)

EADIWEANING

OTHER

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

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

Interventions

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

EADIWEANING

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Marco Ranieri

Co.so Bramante 88, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Professor

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: September 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

IT (1)