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Electrical Activity of the Diaphragm During the Weaning Period

Primary Purpose

Respiratory Insufficiency

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Insufficiency focused on measuring Electrical Activity of Diaphragm, Weaning outcome, NAVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marco Ranieri

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EADIWEANING

Arm Description

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

Outcomes

Primary Outcome Measures

Electrical activity of the diaphragm as a predictor of weaning outcome

Secondary Outcome Measures

Comparison of electrical activity of the diaphragm as a predictor versus other predictors
Evaluation of respiratory parameters during the weaning process

Full Information

First Posted
August 5, 2011
Last Updated
July 31, 2013
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01411722
Brief Title
Electrical Activity of the Diaphragm During the Weaning Period
Official Title
Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Electrical Activity of Diaphragm, Weaning outcome, NAVA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EADIWEANING
Arm Type
Other
Arm Description
Patients mechanically ventilated for more than 48 hours during the weaning process.
Intervention Type
Device
Intervention Name(s)
Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)
Intervention Description
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
Primary Outcome Measure Information:
Title
Electrical activity of the diaphragm as a predictor of weaning outcome
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Comparison of electrical activity of the diaphragm as a predictor versus other predictors
Time Frame
48 hours
Title
Evaluation of respiratory parameters during the weaning process
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Marco Ranieri
City
Co.so Bramante 88
State/Province
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Electrical Activity of the Diaphragm During the Weaning Period

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