NCT03872167

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxemic Respiratory Failure
• Hypercapnic Respiratory Failure

Interventions

Type	Name	Description
DEVICE	BIPAP, Intelligent automatic mode defined by assured volume with pressure support	Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support
DEVICE	BIPAP, manual tritration.	Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.

Timeline

• Start date: 2018-06-15
• Primary completion: 2023-12-31
• Completion: 2024-02-15
• First posted: 2019-03-13
• Last updated: 2024-02-29

Locations

1 site across 1 country: Spain