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

February 27, 2024 updated by: CRISTINA EMBID LOPEZ, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial pressure of carbon dioxide (PaCO2)
Time Frame: two weeks
Measure levels after each polysomnography using arterial blood gases
two weeks
Partial pressure of oxygen (PaO2)
Time Frame: two weeks
Measure levels after each polysomnography using arterial blood gases
two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saving time below 90% (CT90%)
Time Frame: one month
Assess the polysomnography reduction in CT90% through the night study.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: CRISTINA EMBID LOPEZ, PHD, Hospital Clinic
  • Principal Investigator: MONICA C MATUTE VILLACIS, MD, Hospital Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIVHCLINIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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