Clinical trial NCT04677556: Work of Breathing in Bronchiolitis Under Non-invasive Ventilation
Official title: Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Viral Bronchiolitis
Keywords: Severe acute bronchiolitis
Non-invasive positive pressure ventilation
Continuous positive airway pressure
Work of breathing
Pediatric intensive care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 20
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is continuous positive airway pressure (CPAP), which reduces the work of breathing (WOB) and improves gas exchange. Although Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation, no study has yet evaluated if this support could effectively reduce the effort of breathing.

Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis.

The purpose of this study is to compare WOB between CPAP and NiPPV, thanks to esophageal pressure measurement, in infants hospitalized for severe acute bronchiolitis.

Detailed description: Severe acute viral bronchiolitis is the leading cause of pediatric intensive care admission. The first-line recommended ventilation support is non invasive ventilation (NIV) with continuous positive airway pressure (CPAP), which has been proved to reduce the work of breathing (WOB) and improve gas exchange. Non invasive Positive Pressure Ventilation (NiPPV) is increasingly used in case of CPAP failure to avoid intubation. Nevertheless, no study has ever evaluated its effectiveness on the discharge of respiratory muscles in severe bronchiolitis.

Measurement of esophageal and gastric pressures with an esogastric catheter allows an estimation of WOB thanks to the calculation of the esophageal pressure-time product (PTPes), and a calculation of the transdiaphragmatic pressure (Pdi) as the difference between gastric and esophageal pressures. This minimally invasive technique can be used at the bedside to assess the efficacy of ventilation support and is now increasingly used in Intensive Care Units to assist ventilation-targeted strategies.

Our hypothesis is that NiPPV could reduce WOB more effectively than CPAP alone, and might lead to reduce intubation in the most severe bronchiolitis.

The main purpose of this study is to compare PTPes/min between CPAP and NiPPV in infants hospitalized for severe acute bronchiolitis.

Secondary objectives are i) to compare other parameters of WOB, gas exchanges and breathing pattern in both ventilator supports ii) to compare the rate of patient-ventilator asynchronies in 2 different setting of NiPPV ("clinical" and "physiological") iii) to assess if NiPPV is associated with reduced intubation rate, time under sedation and ventilation, and length of hospitalization as compared to CPAP.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of bronchiolitis
* Need for non-invasive ventilation support (NiPPV or CPAP) with a modified Wood clinical asthma score (m-WCAS)\> 4 and / or hypercapnic acidosis (pH \<7.3 and / or pCO2\> 50mmHg)
* Written parental informed consent

Exclusion Criteria:

* Contraindication to nasogastric tube (recent surgery of the esophagus, esophageal malformation at risk of perforation, severe coagulopathy)
* Absolute or relative contraindication to NIV

  * Respiratory collapse: coma (GCS \<12) and / or more than 3 apneas per hour with bradycardia \<90 / min and / or SpO2 \<90%
  * Pneumothorax
* Preexisting disorder that may influence WOB

  * Neuromuscular disease
  * Chronic respiratory failure already under NIV or tracheostomy at home
* No social security

Primary outcomes:
measure: Esophageal pressure-time product per minute (PTPes/min)
timeFrame: 20 minutes
Secondary outcomes:
measure: Respiratory rate (RR)
timeFrame: 20 minutes
measure: Heart rate (HR)
timeFrame: 20 minutes
measure: Inspiratory time (Ti)
timeFrame: 20 minutes
measure: Total respiratory cycle time (Ttot)
timeFrame: 20 minutes
measure: Tidal volume (Vt)
timeFrame: 20 minutes
measure: Gas exchange
timeFrame: 3 hours
measure: Modified Wood's Clinical Asthma Score (m-WCAS)
timeFrame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
measure: PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2)
timeFrame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion
measure: Work of breathing
timeFrame: 20 minutes
measure: Need for intubation
timeFrame: Through study completion, an average of 2 years
measure: Number of days under sedation by Midazolam IV or per os upon hospital discharge
timeFrame: Through study completion, an average of 2 years
measure: Number of days under NIV
timeFrame: Through study completion, an average of 2 years
measure: Number of days under invasive ventilation
timeFrame: Through study completion, an average of 2 years
measure: Number of days in intensive care unit
timeFrame: Through study completion, an average of 2 years
measure: Number of days in hospitalization
timeFrame: Through study completion, an average of 2 years
measure: Patient-ventilator asynchronies (under NiPPV)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Meryl VEDRENNE-CLOQUET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte FAUROUX, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Vedrenne-Cloquet M, Khirani S, Griffon L, Collignon C, Renolleau S, Fauroux B. Respiratory effort during noninvasive positive pressure ventilation and continuous positive airway pressure in severe acute viral bronchiolitis. Pediatr Pulmonol. 2023 Jul;58(7):2000-2008. doi: 10.1002/ppul.26424. Epub 2023 Apr 25.