Active — Not RecruitingNot Applicable

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

France, Poland, Switzerland75 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * D…

What they're measuring

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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.

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

Trial details

NCT IDNCT06114992

SponsorMaquet Critical Care AB

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Elective HFOV for Respiratory Failure in Neonates/Infants trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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)

Timeframe: 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.

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