PROPOSITIS: Prone Position in Acute Bronchiolitis

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03976895

Collaborator

(none)

452

Enrollment

Locations

Arms

21.6

Anticipated Duration (Months)

34.8

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Viral Bronchiolitis	Procedure: Supine position (SP) Procedure: Prone position (PP)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

452 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 13, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Supine position (SP) Supine position (SP) combined with HFNC	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.
Experimental: Prone position (PP) Prone position (SP) combined with HFNC	Procedure: 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.

Arm

Intervention/Treatment

Other: Supine position (SP)

Supine position (SP) combined with HFNC

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.

Experimental: Prone position (PP)

Prone position (SP) combined with HFNC

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Proportion of ventilated children in each of the 2 groups [3 days]
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

Secondary Outcome Measures

Proportion of failure [3 days]
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
Causes of failure [3 days]
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
Duration of ventilation [maximum 3 months]
Duration of ventilation (high flow nasal cannula, invasive, non-invasive) in hours. This data will be collected at critical care unit discharge.
Length of stay [maximum 3 months]
Length of stay in days. This data will be collected at hospital discharge.
Oxygenation evaluation [2 hours]
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
Oxygenation evaluation [12 hours]
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
Oxygenation evaluation [24 hours]
Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
Tolerance evaluation [maximum 3 months]
Proportion of skin lesions, vomiting/regurgitation and exclusive enteral nutrition. This data will be collected at critical care unit discharge.
Variation EDIN score (Scale of pain and discomfort of the newborn) between inclusion and after 2 hours [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
Evaluation of the feasibility of maintaining the position [48 hours]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon	Bron	France	69500
2	CHU de Caen, Service de réanimation et surveillance continue pédiatrique	Caen	France	14000
3	CH CHAMBERY Unité de surveillance continue pédiatrique	Chambéry	France	73000
4	Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique	Dijon	France	21079
5	CH VILLEFRANCHE Service de pédiatrie néonatologie	Gleizé	France	69400
6	CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant	La Tronche	France	38700
7	CHU MONTPELLIER Service de réanimation pédiatrique	Montpellier	France	34295
8	CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant	Nantes	France	44093
9	CHU LENVAL NICE Service de réanimation pédiatrique	Nice	France	06200
10	Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales	Paris	France	75015
11	CHU SAINT-ETIENNE Service de réanimation pédiatrique	Saint-Priest-en-Jarez	France	42270
12	CRHU Nancy Réanimation Pédiatrique Spécialisée	Vandœuvre-lès-Nancy	France	54500
13	CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique	Épagny	France	74370