Servo-n HFOV Study: Safety and Performance in Neonates and Infants

NCT06114992 | Active Not Recruiting DMC

• 1 other identifier: EVU-215176
• Study Type: observational
• Target: 75
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm (i.e., non-controlled) and multi-center Post-Market Follow-up (PMCF) study design. HFOV treatment will be evaluated by assessing ventilation and oxygenation variables, and safety will be evaluated by documentation of device related adverse events.

Conditions

Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy; Elective HFOV for Respiratory Failure in Neonates/Infants

Outcome Measures

Primary Outcomes (4)

• Proportion of subjects that achieved and/or maintained target ranges for oxygenation, as measured by preductal Saturation of Peripheral Oxygen (SpO2).

  Oxygenation response, elective HFOV patients

  After Servo-n HFOV treatment, expected treatment duration 1-30 days

• Proportion of subjects that achieved and/or maintained target ranges for ventilation as measured either by Partial Pressure of Carbon Dioxide (PCO2) (if available blood gas) or Transcutaneous Carbon Dioxide (TcCO2)

  Ventilation response, elective HFOV patients

  After Servo-n HFOV treatment, expected treatment duration 1-30 days

• Proportion of subjects that maintained or improved values for oxygenation as measured by the SpO2/FiO2 ratio and/ or achieved target ranges for oxygenation (preductal SpO2)

  Oxygenation response, rescue HFOV patients

  After Servo-n HFOV treatment, expected treatment duration 1-30 days

• Proportion of subjects that maintained or improved values, and/or achieved target ranges, for ventilation as measured either by PCO2 (if available blood gas) or TcCO2.

  Ventilation response, rescue HFOV patients

  After Servo-n HFOV treatment, expected treatment duration 1-30 days

Secondary Outcomes (4)

• The occurrence of reported Servo-n HFOV device (including accessories) deficiencies and adverse device effects and serious adverse device effects (ADE and SADE)

  After Servo-n HFOV treatment, expected treatment duration 1-30 days

• Patient outcome at ICU discharge

  Through study completion (at ICU discharge), expected up to 120 days

• Assessment of oxygenation status

  From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)

• Assessment of ventilation status

  From available blood gas and at Baseline (-4h -2h, -1h, 0h), During HFOV (0h, 30min, 1h, 2h, 4h, 6h. etc every 6 h), Post HFOV (2h, 4h, 6h, 12h and 24h)

Study Arms (1)

Servo-n HFOV treatment

As this study is single-armed (non-controlled), all patients in this study receive the same treatment, i.e. Servo-n HFOV treatment. There are however two subgroups, elective HFOV and rescue HFOV treatment

Device: Servo-n HFOV modes

Interventions

Servo-n HFOV modes DEVICE

Treatment with high frequency oscillatory ventilation with Servo-n device in accordance to Standard of Care

Servo-n HFOV treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both preterm and term (0.3-8 kg) neonatal/infant patient group requiring HFOV treatment. Subjects on elective HFOV and rescue HFOV, will be enrolled from up to 10 sites in European countries.

You may qualify if:

• Provision of written informed consent by the patient's legally designated representative(s) (may be obtained as deferred consent up to 24 hours after HFOV initiation: valid for both elective and rescue HFOV patients)
• Patients eligible for HFOV ventilation with Servo-n:
• Patient is either switched from conventional mechanical ventilation or HFOV with other device to Servo-n HFOV based on clinicians judgement (rescue HFOV). Note: the reason for the switch has to be that the patient failed to oxygenate or ventilate adequately with CMV or the other HFOV device
• ; OR
• Patient was prior without or with any type of non-invasive respiratory support and is put on invasive HFOV treatment based on clinicians judgement (elective HFOV)
• Patient has not already been on HFOV in a previous episode, unless the etiology of respiratory failure has changed during the same hospitalisation. For example, initial HFOV treatment for RDS, second HFOV episode of NARDS of any etiology (will be enrolled as a new patient case). NOTE1: When a patient failed weaning on conventional ventilation within 6 hours, requiring to be put back on HFOV it will be counted as one HFOV episode (weaning failure) NOTE2: When a patient is temporarily put on conventional ventilation for transport or a surgical intervention, and will be put back to HFOV afterwards, it will be counted as one HFOV episode (HFOV paused).
• Patient has a body weight from 0.3 to 8.0 kg

You may not qualify if:

• Diagnosis of congenital diaphragmatic hernia
• Severe cardiac anomaly expected to need corrective surgery or catheter-based intervention within 30 days from birth
• Cyanotic heart disease
• Intracranial hemorrhage, Grade III or IV
• Congenital malformations with the exception of isolated lung hypoplasia
• Persistent pulmonary hypertension (PPHN) with a documented shunt on the level of the foramen ovale
• Bronchopulmonary Dysplasia (BPD) /Chronic Lung Disease (CLD)

Sponsors & Collaborators

• Maquet Critical Care AB: lead
• NAMSA: collaborator
• Paediatric and Neonatal Mechanical Ventilation (PNV) Consulting: collaborator

Study Sites (4)

CHU Montpellier-Arnaud de Villeneuve

Montpellier, France

Location

Antoine-Béclère Hospital

Paris, France

Location

Poznan University of Medical Sciences

Poznan, Poland

Location

University Hospital of Geneva (HUG)

Geneva, Switzerland

Location

Study Officials

• Peter Rimensberger, Prof. MD

  PNV consulting

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 2, 2023
• Study Start: July 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (2); PL (1); CH (1)