Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

Not Applicable

Completed

• Conditions: Hypercapnic Respiratory Failure; Hypoxemic Respiratory Failure
• Interventions: Device: BIPAP, manual tritration.; Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support

• Registration Number: NCT03872167
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.

Detailed Description

Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Study Completion: 2024-02-15
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

chronic respiratory failure

• Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)

Exclusion Criteria

• Under 18 years old.
• Presence of severe uncontrolled cardiac comorbidity.
• Impossibility to achieve adaptation to therapy in the training session.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MANUAL	BIPAP, manual tritration.	Manual titration of non-invasive mechanical ventilation using polysomnography and randomized
AUTOMATIC	BIPAP, Intelligent automatic mode defined by assured volume with pressure support	Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.

Primary Outcome Measures

Name	Time	Method
Partial pressure of oxygen (PaO2)	two weeks	Measure levels after each polysomnography using arterial blood gases
Partial pressure of carbon dioxide (PaCO2)	two weeks	Measure levels after each polysomnography using arterial blood gases

Secondary Outcome Measures

Name	Time	Method
Oxygen saving time below 90% (CT90%)	one month	Assess the polysomnography reduction in CT90% through the night study.

Trial Locations

Locations (1)

Hospital Clinic Barcelona.; 🇪🇸 Barcelona, Spain