Status:
COMPLETED
Electrical Activity of the Diaphragm During the Weaning Period
Lead Sponsor:
University of Turin, Italy
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ventilatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01411722
Start Date
September 1 2008
End Date
June 1 2012
Last Update
August 1 2013
Active Locations (1)
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1
Marco Ranieri
Co.so Bramante 88, Torino, Italy, 10126