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Completed

NCT Number: NCT01322659

Weaning Using Noninvasive Positive Pressure Ventilation by Means of Helmet in Patients With Acute Respiratory Failure

The purpose of this study is to determine whether helmet is effective as device for noninvasive positive pressure ventilation in the weaning from mechanical ventilation.

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Key information

Conditions

Inadequate or Impaired Breathing Pattern or Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Hospital

Padova, 35128, Italy

About this study

The clinical efficacy of noninvasive positive pressure ventilation (NPPV) has been demonstrated. Interest has emerged in using NPPV to facilitate earlier removal of an endotracheal tube and decrease complications associated with prolonged intubation. Studies assessing NPPV in weaning are not enough and generally are performed with face masks as device for NPPV. This study assesses the efficacy of helmet as device for NPPV during weaning from mechanical ventilation in an ICU and compares this procedure with invasive mechanical complication (IMV) by analyzing respiratory parameters, clinical course and complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • endotracheal mechanical ventilation for 48 hours or more for acute respiratory failure,
  • patient ready to be weaned (steady respiratory and hemodynamic conditions for 24 hours),
  • spontaneous breathing trial failure
  • written informed consent obtained (patient or family)

Exclusion criteria

  • respiratory and hemodynamic instability
  • initial difficult intubation
  • bronchial hypersecretion at the weaning time
  • non cooperant patient
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction

Treatment and study plan

Helmet

Device

Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet

Endotracheal tube

Device

Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube

Primary outcomes

  1. Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure

    Time frame: 30 days

    Main end-point defined as the weaning success/failure rate

Secondary outcomes

  1. Weaning using noninvasive positive pressure ventilation by means of helmet in patients with acute respiratory failure

    Time frame: 180 days

    • Intubation duration
    • Total duration of mechanical ventilation (endotracheal and non invasive)
    • Weaning process duration
    • Stress response evaluation
    • Daily duration of ventilatory support
    • ICU lentgh of stay
    • Hospital lentgh of stay

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2011
Registry last updated
Jan 31, 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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