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Completed

NCT Number: NCT01411722

Electrical Activity of the Diaphragm During the Weaning Period

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marco Ranieri

Co.so Bramante 88, Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Electrical activity of the diaphragm as a predictor of weaning outcome

    Time frame: 48 hours

Secondary outcomes

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

    Time frame: 48 hours

  2. Evaluation of respiratory parameters during the weaning process

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Electrical Activity of the Diaphragm in Mechanically Ventilated Patients During the Weaning Period

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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