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NCT03872167 Clinical Trial

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

Hypercapnic Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03872167
Other study ID # NIVHCLINIC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2018
Est. completion date February 15, 2024

Study information
Verified date February 2024
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date February 15, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• BIPAP, manual tritration.
Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.

Locations
Country Name City State
Spain Hospital Clinic Barcelona. Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Partial pressure of carbon dioxide (PaCO2) Measure levels after each polysomnography using arterial blood gases two weeks
Primary Partial pressure of oxygen (PaO2) Measure levels after each polysomnography using arterial blood gases two weeks
Secondary Oxygen saving time below 90% (CT90%) Assess the polysomnography reduction in CT90% through the night study. one month
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