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Electrical Activity of the Diaphragm During the Weaning Period

This study is currently recruiting participants.
Verified August 2011 by University of Turin, Italy
Sponsor:
Information provided by (Responsible Party):
Marco Ranieri, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01411722
First received: August 5, 2011
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Respiratory Insufficiency
 Device: Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Electrical activity of the diaphragm as a predictor of weaning outcome [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of electrical activity of the diaphragm as a predictor versus other predictors [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Evaluation of respiratory parameters during the weaning process [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
EADIWEANING
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)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411722

Contacts
Contact: Vito Marco Ranieri, MD +39 0116334001 marco.ranieri@unito.it
Contact: Gabriela Ferreyra, MSC +39 0116334001 gabriela.ferreyra@unito.it

Locations
Italy
Marco Ranieri Recruiting
Co.so Bramante 88, Torino, Italy, 10126
Contact: Gabriela Ferreyra, MSC     +39 0116334001     gabriela.ferreyra@unito.it    
Sponsors and Collaborators
University of Turin, Italy
  More Information

No publications provided

Responsible Party: Marco Ranieri, MD Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01411722     History of Changes
Other Study ID Numbers: EADIWEANIG299
Study First Received: August 5, 2011
Last Updated: August 23, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
Electrical Activity of Diaphragm
Weaning outcome
NAVA

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013