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Completed

NCT Number: NCT04677556

Work of Breathing in Bronchiolitis Under Non-invasive Ventilation

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.

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Key information

Conditions

Severe Viral Bronchiolitis Bronchial Diseases Bronchiolitis Bronchiolitis, Viral Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esogastric pressures measurement

Other

Catheter placement : at least 2 hours after and within 24 hours following the initial ventilation support establishment (CPAP or NiPPV according to usual practice and clinical conditions). 2 periods of measurements : with the initial and with the 2nd ventilation support using a cross-over for each patient. For each period, the first serie of measurements will be carried out without modifying the settings of the support ( "clinical" setting), and the second one using esogastric pressures by adjusting the settings of the ventilation support in order to obtain an optimal normalization or reduction of the amplitude of the Pes and Pdi deltas ("physiological" setting). 5 minutes of spontaneous breathing with/without oxygen between period 1 and 2 (depending on the patient's conditions). All measurements will be performed for 5 minutes after a 15 minutes quiet breathing. After measurements, the optimal respiratory support will be continued.

Primary outcomes

  1. Esophageal pressure-time product per minute (PTPes/min)

    Time frame: 20 minutes

    Esophageal pressure-time product per minute (PTPes/min) is calculated by the area under the curve of the Pes during inspiration, expressed in cmH2O.s / min.

    The PTPes/min will be measured under CPAP (" clinical" and "physiological" setting) and under NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

Secondary outcomes

  1. Respiratory rate (RR)

    Time frame: 20 minutes

    Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  2. Heart rate (HR)

    Time frame: 20 minutes

    In pulses per minute Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  3. Inspiratory time (Ti)

    Time frame: 20 minutes

    In sec Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  4. Total respiratory cycle time (Ttot)

    Time frame: 20 minutes

    In sec Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  5. Tidal volume (Vt)

    Time frame: 20 minutes

    In mL Breathing pattern Paramaters will be measured under CPAP ("clinical" and "physiological" setting) and NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  6. Gas exchange

    Time frame: 3 hours

    SpO2 and PtcCO2, in mmHg will be continuously monitored thanks to a pulse oxymeter and transcutaneous capnography (SenTecTM) for 3 hours

  7. Modified Wood's Clinical Asthma Score (m-WCAS)

    Time frame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion

    Modified Wood's Clinical Asthma Score (m-WCAS) is a respiratory failure score that includes 3 levels of gravity corresponding to 5 respiratory distress clinical signs. Values ranged from 0 (best score) to 10 (worst score)

  8. PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2)

    Time frame: At inclusion and at the end of the measurements, i.e. 3 hours from inclusion

    Pediatric logistic organ dysfunction score is a specific pediatric multiple organ dysfunction score that includes 10 variables corresponding to 5 organ dysfunctions. Values extend from 0 (best outcome) to 33 (worst outcome).

  9. Work of breathing

    Time frame: 20 minutes

    Esophageal pressure delta (ΔPES, normal between 5 and 8 cmH2O) Transdiaphragmatic pressure delta (ΔPdi). The Pdi is obtained by subtracting the Pes from the Pgas Pressure-time product of the diaphragm per minute (PTPDdi/min).

    Paramaters will be measured under CPAP (" clinical" and "physiological" setting) and under NiPPV (" clinical" and "physiological" setting) during a period of quiet breathing of 5 minutes.

  10. Need for intubation

    Time frame: Through study completion, an average of 2 years

  11. Number of days under sedation by Midazolam IV or per os upon hospital discharge

    Time frame: Through study completion, an average of 2 years

  12. Number of days under NIV

    Time frame: Through study completion, an average of 2 years

  13. Number of days under invasive ventilation

    Time frame: Through study completion, an average of 2 years

  14. Number of days in intensive care unit

    Time frame: Through study completion, an average of 2 years

  15. Number of days in hospitalization

    Time frame: Through study completion, an average of 2 years

  16. Patient-ventilator asynchronies (under NiPPV)

    Time frame: Through study completion, an average of 2 years

    Patient-ventilator asyncrhonies will be analyzed using the flow and pressure curves of the ventilator and the patient (Pes), then classified into 4 groups:

    • auto-triggering (cycle delivered by the ventilator without patient's inspiratory effort),
    • double triggering (2 successive cycles delivered by the ventilator for a single inspiratory effort of the patient),
    • wasted effort (patient inspiratory effort not followed by a cycle delivered by the ventilator),
    • daly asynchronies (advance or delay of the cycle delivered by the ventilator compared to the start of the patient's inspiration or expiration) The percentage of patient-ventilator asynchronies will be analyzed under NiPPV ("clinical" setting and "physiological" setting) during a period of quiet breathing of 5 minutes.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation

Acronym: BRONCHIO-VNI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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