Severe Viral Bronchiolitis Clinical Trial
— BRONCHIO-VNIOfficial title:
Comparison Between Continuous Positive Airway Pressure (CPAP) and Non Invasive Positive Pressure Ventilation (NiPPV) in Bronchiolitis Under Non- Invasive Ventilation
| Verified date | May 2023 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | January 8, 2022 |
| Est. primary completion date | January 8, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 6 Months |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker-Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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 Apr 25. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Esophageal pressure-time product per minute (PTPes/min) | 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. |
20 minutes | |
| Secondary | Respiratory rate (RR) | 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. | 20 minutes | |
| Secondary | Heart rate (HR) | 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. | 20 minutes | |
| Secondary | Inspiratory time (Ti) | 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. | 20 minutes | |
| Secondary | Total respiratory cycle time (Ttot) | 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. | 20 minutes | |
| Secondary | Tidal volume (Vt) | 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. | 20 minutes | |
| Secondary | Gas exchange | SpO2 and PtcCO2, in mmHg will be continuously monitored thanks to a pulse oxymeter and transcutaneous capnography (SenTecTM) for 3 hours | 3 hours | |
| Secondary | Modified Wood's Clinical Asthma Score (m-WCAS) | 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) | At inclusion and at the end of the measurements, i.e. 3 hours from inclusion | |
| Secondary | PEdiatric Logistic Organ Dysfunction-2 score (PELOD-2) | 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). | At inclusion and at the end of the measurements, i.e. 3 hours from inclusion | |
| Secondary | Work of breathing | Esophageal pressure delta (?PES, normal between 5 and 8 cmH2O) Transdiaphragmatic pressure delta (?Pdi). 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. |
20 minutes | |
| Secondary | Need for intubation | Through study completion, an average of 2 years | ||
| Secondary | Number of days under sedation by Midazolam IV or per os upon hospital discharge | Through study completion, an average of 2 years | ||
| Secondary | Number of days under NIV | Through study completion, an average of 2 years | ||
| Secondary | Number of days under invasive ventilation | Through study completion, an average of 2 years | ||
| Secondary | Number of days in intensive care unit | Through study completion, an average of 2 years | ||
| Secondary | Number of days in hospitalization | Through study completion, an average of 2 years | ||
| Secondary | Patient-ventilator asynchronies (under NiPPV) | 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. |
Through study completion, an average of 2 years |