Prone Position in Acute Bronchiolitis

Acute Viral Bronchiolitis Clinical Trial

— PROPOSITIS  

Official title:

Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976895
• Other study ID #: 69HCL19_0333
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Hospices Civils de Lyon
• Contact: Florent BAUDIN, Dr
• Phone: 04 72 12 97 35
• Email: florent.baudin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support. Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU. In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis. Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Infant under 6 months
• Hospitalized in critical care unit (continuous monitoring unit or intensive care unit)
• With a clinical diagnosis of acute viral bronchiolitis (criterion of the American Academy of Pediatrics 2014)
• m-WCAS score = 3 and / or hypercapnic acidosis with pH <7.35 and pCO2> 50mmHg (6.7 kPa)
• Informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file.

Exclusion Criteria:

• Infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with pH <7.25 without ventilatory support and/or hypoxia with impossibility of maintaining SpO2> 92% whatever the FiO2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder)
• Patient already positioned in the prone position before randomization
• Significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), Ear Nose and Throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease.
• Contraindication to Prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy
• Patient who is not affiliated (or does not benefit from) to a national social security system

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Procedure:
• Supine position (SP)
Infants under high flow nasal cannula (HFNC) will be positioned in the supine position. Patients may be positioned temporarily in lateral position between periods of supine position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.
• Prone position (PP)
Infants under high flow nasal cannula (HFNC) will be placed in the prone position during at least 24 hours over the first 48 hours. The positioning will be standardized (chest on the bed plan and abdomen cleared) and children should be placed in the prone position immediately after randomization. Patients may be positioned temporarily in lateral position between periods of prone position to limit ventilatory disorders, as it is usually done in critical care units during bronchiolitis.

Locations

Country	Name	City	State
France	Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon	Bron
France	CHU de Caen, Service de réanimation et surveillance continue pédiatrique	Caen
France	CH CHAMBERY Unité de surveillance continue pédiatrique	Chambéry
France	Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique	Dijon
France	CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique	Épagny
France	CH VILLEFRANCHE Service de pédiatrie néonatologie	Gleizé
France	CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant	La Tronche
France	CHU MONTPELLIER Service de réanimation pédiatrique	Montpellier
France	CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant	Nantes
France	CHU LENVAL NICE Service de réanimation pédiatrique	Nice
France	Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales	Paris
France	CHU SAINT-ETIENNE Service de réanimation pédiatrique	Saint-Priest-en-Jarez
France	CRHU Nancy Réanimation Pédiatrique Spécialisée	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of ventilated children in each of the 2 groups	Indications for the use of ventilation (invasive or non-invasive ventilation) will be standardized in both groups (based on the interregional protocol for the management of bronchiolitis): Clinical aggravation defined by an increase = 1 point of the m-WCAS score; Persistence of hypercapnic acidosis with pH =7.30 and pCO2= 8 kPa or FiO2> 60% under HFNC at 2 L/kg/min; More than 2 significant apneas per hour (apnea with desaturation <90% and / or bradycardia <90 / min); Consciousness disorder; Anytime over the first 3 days after inclusion	3 days
Secondary	Proportion of failure	Failure is defined as: HFNC failure (composite failure criterion validated by an independent committee); worsening of mWCAS score = 1 point; hypercapnic acidosis (pH =7.30 and pCO2=8kPa); significant apnea (apnea with desaturation <90% and / or bradycardia <90/min); Anytime over the first 3 days after inclusion	3 days
Secondary	Causes of failure	Failure is defined as: HFNC failure (composite failure criterion validated by an independent committee); worsening of mWCAS score = 1 point; hypercapnic acidosis (pH =7.30 and pCO2=8kPa); significant apnea (apnea with desaturation <90% and / or bradycardia <90/min); Anytime over the first 3 days after inclusion	3 days
Secondary	Duration of ventilation	Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours.; This data will be collected at critical care unit discharge.	maximum 3 months
Secondary	Length of stay	Length of stay in days. This data will be collected at hospital discharge.	maximum 3 months
Secondary	Oxygenation evaluation	Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.	2 hours
Secondary	Oxygenation evaluation	Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.	12 hours
Secondary	Oxygenation evaluation	Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.	24 hours
Secondary	Tolerance evaluation	Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition.; This data will be collected at critical care unit discharge.	maximum 3 months
Secondary	Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours	Scale ranges to 0 from 15 and is a combination of criteria: Face: Relaxed=0 to Permanent tightness or prostrate face,frozen or purple face=3; Body: Relaxed=0 to Permanent agitation,tightness of extremities and stiffness of limbs or very poor and limited motor skills with fixed body=3; Sleep:Easily, extended and calm=0 to No sleep=3; Relationship:Smile to the angels,smile answer,attentive to the listening=0 to Refuses contact,no relationship possible,howl or moan without any stimulation=3; Comfort: Do not need comfort=0 to Inconsolable,desperate sucking=3	2 hours
Secondary	Evaluation of the feasibility of maintaining the position	Proportion of children in the prone position repositioned definitively in the supine position before performing the cumulative 24 hours of prone position, cumulative hours of prone position in the first 48 hours	48 hours