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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872167
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
CRISTINA EMBID LOPEZ, 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Partial pressure of carbon dioxide (PaCO2) [ Time Frame: two weeks ]
    Measure levels after each polysomnography using arterial blood gases

  2. Partial pressure of oxygen (PaO2) [ Time Frame: two weeks ]
    Measure levels after each polysomnography using arterial blood gases


Secondary Outcome Measures :
  1. Oxygen saving time below 90% (CT90%) [ Time Frame: one month ]
    Assess the polysomnography reduction in CT90% through the night study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: MONICA C MATUTE VILLACIS, MD 932275746 matute@clinic.cat

Locations
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Spain
Hospital Clinic Barcelona. Recruiting
Barcelona, Spain, 08036
Contact: Hospital Clinic       matute@clinic.cat   
Sub-Investigator: Monica C Matute Villacís, Pneumology         
Principal Investigator: Cristina Embid Lopez, Pneumology         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: CRISTINA EMBID LOPEZ, PHD Hospital Clinic

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Responsible Party: CRISTINA EMBID LOPEZ, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03872167    
Other Study ID Numbers: NIVHCLINIC
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona:
NIV
hypoxemia
hypercapnia
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases