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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01411722
Other study ID # EADIWEANIG299
Secondary ID
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


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
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