NCT01322659

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 31, 2013

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

March 21, 2011

Last Update Submit

January 30, 2013

Conditions

Inadequate or Impaired Breathing Pattern or Ventilation

Keywords

Mechanical ventilationWeaningNoninvasive ventilationAcute respiratory failureHelmet

Outcome Measures

Primary Outcomes (1)

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

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

    30 days

Secondary Outcomes (1)

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

    180 days

Study Arms (2)

Helmet NPPV

ACTIVE COMPARATOR

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

Device: Helmet

ETT IMV

SHAM COMPARATOR

Weaning from mechanical ventilation with standard invasive mechanical ventilation (IMV) delivered by means of the endotracheal tube (ETT)

Device: Endotracheal tube

Interventions

HelmetDEVICE

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

Helmet NPPV
Endotracheal tubeDEVICE

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

ETT IMV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Hospital

Padua, 35128, Italy

Location

Related Publications (1)

  • Carron M, Rossi S, Carollo C, Ori C. Comparison of invasive and noninvasive positive pressure ventilation delivered by means of a helmet for weaning of patients from mechanical ventilation. J Crit Care. 2014 Aug;29(4):580-5. doi: 10.1016/j.jcrc.2014.03.035. Epub 2014 Apr 5.

    PMID: 24793658DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Head Protective Devices

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Michele Carron, MD

    University medical hospital of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 24, 2011

Study Start

March 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 31, 2013

Record last verified: 2011-03

Locations

IT(1)