Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
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|ClinicalTrials.gov Identifier: NCT03872167|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypoxemic Respiratory Failure Hypercapnic Respiratory Failure||Device: BIPAP, Intelligent automatic mode defined by assured volume with pressure support Device: BIPAP, manual tritration.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||May 15, 2020|
Active Comparator: MANUAL
Manual titration of non-invasive mechanical ventilation using polysomnography and randomized
Device: BIPAP, manual tritration.
Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.
Active Comparator: AUTOMATIC
Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.
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
- Partial pressure of carbon dioxide (PaCO2) [ Time Frame: two weeks ]Measure levels after each polysomnography using arterial blood gases
- Partial pressure of oxygen (PaO2) [ Time Frame: two weeks ]Measure levels after each polysomnography using arterial blood gases
- Oxygen saving time below 90% (CT90%) [ Time Frame: one month ]Assess the polysomnography reduction in CT90% through the night study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872167
|Contact: MONICA C MATUTE VILLACIS, MDfirstname.lastname@example.org|
|Hospital Clinic Barcelona.||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Hospital Clinic email@example.com|
|Sub-Investigator: Monica C Matute Villacís, Pneumology|
|Principal Investigator: Cristina Embid Lopez, Pneumology|
|Principal Investigator:||CRISTINA EMBID LOPEZ, PHD||Hospital Clinic|