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Prone Position in Acute Bronchiolitis (PROPOSITIS)
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) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 420 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 : | January 13, 2021 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
| Arm | Intervention/treatment |
|---|---|
|
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. |
- Proportion of ventilated children in each of the 2 groups [ Time Frame: 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
- Proportion of failure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: maximum 3 months ]Length of stay in days. This data will be collected at hospital discharge.
- Oxygenation evaluation [ Time Frame: 2 hours ]Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H2.
- Oxygenation evaluation [ Time Frame: 12 hours ]Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H12.
- Oxygenation evaluation [ Time Frame: 24 hours ]Evolution of FiO2 and SpO2/FiO2 ratio between inclusion and H24.
- Tolerance evaluation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
| Ages Eligible for Study: | up to 6 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 during the epidemic period (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, hypoxia with impossibility of maintaining SpO2> 92% whatever the FiO2, more than 3 significant apneas per hour, severe consciousness disorder)
- Patient already positioned in the prone position before randomization
- Significant comorbidities with a history of respiratory pathology (bronchodysplasia), 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
| Contact: Florent BAUDIN, Dr | 04 72 12 97 35 ext +33 | florent.baudin@chu-lyon.fr | |
| Contact: Tiphanie GINHOUX | 04 27 85 77 23 ext +33 | tiphanie.ginhoux@chu-lyon.fr |
| France | |
| Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon | Recruiting |
| Bron, France, 69500 | |
| Contact: Florent BAUDIN, Dr 04 72 12 97 35 ext +33 florent.baudin@chu-lyon.fr | |
| Contact: Tiphanie GINHOUX 04 27 85 77 23 ext +33 tiphanie.ginhoux@chu-lyon.fr | |
| Principal Investigator: Florent BAUDIN, Dr | |
| CH CHAMBERY Unité de surveillance continue pédiatrique | Recruiting |
| Chambéry, France, 73000 | |
| Contact: Corinne PAGET 04 79 96 61 60 ext +33 Corinne.Paget@ch-metropole-savoie.fr | |
| CH VILLEFRANCHE Service de pédiatrie néonatologie | Recruiting |
| Gleizé, France, 69400 | |
| Contact: Marie TOCHON TEIXEIRA 04 74 09 28 39 ext +33 MTochon@lhopitalnordouest.fr | |
| CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant | Recruiting |
| La Tronche, France, 38700 | |
| Contact: Guillaume MORTAMET 04 76 76 55 03 ext +33 gmortamet@chu-grenoble.fr | |
| CHU MONTPELLIER Service de réanimation pédiatrique | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Christophe MILESI 04 67 33 66 09 ext +33 c-milesi@chu-montpellier.fr | |
| CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant | Recruiting |
| Nantes, France, 44093 | |
| Contact: Jean Eudes PILOQUET piloquet.jeaneudes@gmail.com | |
| CHU LENVAL NICE Service de réanimation pédiatrique | Recruiting |
| Nice, France, 06200 | |
| Contact: Mickael AFFANETI 04 92 03 04 08 ext +33 afanetti.m@pediatrie-chulenval-nice.fr | |
| Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales | Recruiting |
| Paris, France, 75015 | |
| Contact: Sylvain RENOLLEAU 01 44 49 56 67 ext +33 sylvain.renolleau@aphp.fr | |
| CHU SAINT-ETIENNE Service de réanimation pédiatrique | Recruiting |
| Saint-Priest-en-Jarez, France, 42270 | |
| Contact: François BARRIERE 04 77 82 83 85 ext +33 francois.barriere@chu-st-etienne.fr | |
| CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique | Recruiting |
| Épagny, France, 74370 | |
| Contact: Clémence JARASSE 04 50 63 63 24 ext +33 cjarrasse@ch-annecygenevois.fr | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||||||
| First Posted Date ICMJE | June 6, 2019 | ||||||||
| Last Update Posted Date | January 22, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 13, 2021 | ||||||||
| Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of ventilated children in each of the 2 groups [ Time Frame: 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):
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prone Position in Acute Bronchiolitis | ||||||||
| Official Title ICMJE | Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Acute Viral Bronchiolitis | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
420 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 2022 | ||||||||
| Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 6 Months (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03976895 | ||||||||
| Other Study ID Numbers ICMJE | 69HCL19_0333 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Hospices Civils de Lyon | ||||||||
| Study Sponsor ICMJE | Hospices Civils de Lyon | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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