Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs

NCT02977585 | Terminated

• 1 other identifier: 1239_OPBG_2016
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill Severe Bronchiolitis

Keywords

continous positive airway pressure; helmet; non invasive; positive end expiratory pressure; severe bronchiolitis; pediatric intensive care unit

Outcome Measures

Primary Outcomes (2)

• incidence of intubation following Helmet CPAP treatment

  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.

  7 days

• incidence of pneumothorax following Helmet CPAP treatment

  pneumothorax occurrence

  72 hours

Secondary Outcomes (1)

• length of stay

  days 30

Study Arms (2)

group 1

ACTIVE COMPARATOR

high level support

Device: 10 cmH2O peep

group 0

NO INTERVENTION

low level support

Interventions

10 cmH2O peep DEVICE

positive end expiratory pressure

group 1

Eligibility Criteria

• Age: 38 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Bambino Gesù Children's Hospital

Rome, Lazio, 00100, Italy

Location

Related Publications (7)

• Donlan M, Fontela PS, Puligandla PS. Use of continuous positive airway pressure (CPAP) in acute viral bronchiolitis: a systematic review. Pediatr Pulmonol. 2011 Aug;46(8):736-46. doi: 10.1002/ppul.21483. Epub 2011 May 26.

  PMID: 21618716 BACKGROUND

• Mayfield S, Bogossian F, O'Malley L, Schibler A. High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. J Paediatr Child Health. 2014 May;50(5):373-8. doi: 10.1111/jpc.12509. Epub 2014 Feb 25.

  PMID: 24612137 BACKGROUND

• Trevisanuto D, Camiletti L, Doglioni N, Cavallin F, Udilano A, Zanardo V. Noise exposure is increased with neonatal helmet CPAP in comparison with conventional nasal CPAP. Acta Anaesthesiol Scand. 2011 Jan;55(1):35-8. doi: 10.1111/j.1399-6576.2010.02356.x. Epub 2010 Nov 15.

  PMID: 21077846 BACKGROUND

• Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.

  PMID: 25780074 BACKGROUND

• Ganu SS, Gautam A, Wilkins B, Egan J. Increase in use of non-invasive ventilation for infants with severe bronchiolitis is associated with decline in intubation rates over a decade. Intensive Care Med. 2012 Jul;38(7):1177-83. doi: 10.1007/s00134-012-2566-4. Epub 2012 Apr 18.

  PMID: 22527081 BACKGROUND

• Milani GP, Plebani AM, Arturi E, Brusa D, Esposito S, Dell'Era L, Laicini EA, Consonni D, Agostoni C, Fossali EF. Using a high-flow nasal cannula provided superior results to low-flow oxygen delivery in moderate to severe bronchiolitis. Acta Paediatr. 2016 Aug;105(8):e368-72. doi: 10.1111/apa.13444. Epub 2016 May 16.

  PMID: 27102726 BACKGROUND

• American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.

  PMID: 17015575 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 30, 2016
• Study Start: November 2, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

IT (1)