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Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Emanuele Rossetti, Bambino Gesù Hospital and Research Institute
Sponsor:
Information provided by (Responsible Party):
Emanuele Rossetti, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT02977585
First received: November 17, 2016
Last updated: November 29, 2016
Last verified: November 2016
  Purpose

Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25 patients at least.

  • 10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU admission (random 1)
  • 5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2 occurs in the following first hour after Helmet CPAP treatment start, patients enrolled will receive endotracheal intubation, full face mask non invasive ventilation or higher peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.

In investigator's experience, early worsening of severe bronchiolitis in PICU in the first hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.


Condition Intervention
Critically Ill Severe Bronchiolitis Device: 10 cmH2O peep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Helmet Continous Positive Airway Pressure (CPAP) Management and Positive End Expiratory Pressure (PEEP) Level Impact on Severe Bronchiolitis Admitted in Pediatric Intensive Care Units (PICUs)

Further study details as provided by Emanuele Rossetti, Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • incidence of intubation following Helmet CPAP treatment [ Time Frame: 7 days ]
    to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 peep level in group 1, and 5 peep level in group 0.

  • incidence of pneumothorax following Helmet CPAP treatment [ Time Frame: 72 hours ]
    pneumothorax occurrence


Secondary Outcome Measures:
  • length of stay [ Time Frame: days 30 ]
    length of PICU stay


Estimated Enrollment: 488
Study Start Date: November 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 1
high level support
Device: 10 cmH2O peep
positive end expiratory pressure
No Intervention: group 0
low level support

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   38 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of 38 weeks of gestational age up to 18 months old, admitted in PICU for severe bronchiolitis, whose parents have signed written informed consent to enroll the child in the study.
  • Patients with severe bronchiolitis moved from emergency department, pediatric ward, and supported up to 72 hours with HFNC or O2 therapy.

Exclusion Criteria:

  • Severe congenital malformation Inborn congenital error Neonatal or postnatal neurologic disorder Parents refusal to study participation Presence or supposed pneumothorax on chest X-ray or lung ultrasound
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02977585

Locations
Italy
Bambino Gesù Children's Hospital Recruiting
Rome, Lazio, Italy, 00100
Contact: emanuele rossetti, md    3478370026 ext 0039    emanuele.rossetti@opbg.net   
Contact    3478370026 ext 0039    emanuele.rossetti@opbg.net   
Principal Investigator: emanuele rossetti, md         
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
  More Information

Publications:

Responsible Party: Emanuele Rossetti, md, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02977585     History of Changes
Other Study ID Numbers: 1239_OPBG_2016
Study First Received: November 17, 2016
Last Updated: November 29, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Emanuele Rossetti, Bambino Gesù Hospital and Research Institute:
continous positive airway pressure
helmet
non invasive
positive end expiratory pressure
severe bronchiolitis
pediatric intensive care unit

Additional relevant MeSH terms:
Critical Illness
Bronchiolitis
Disease Attributes
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 21, 2017