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Clinical Trials/NCT03872167
NCT03872167
Completed
Not Applicable

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

Hospital Clinic of Barcelona1 site in 1 country26 target enrollmentJune 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxemic Respiratory Failure
Sponsor
Hospital Clinic of Barcelona
Enrollment
26
Locations
1
Primary Endpoint
Partial pressure of oxygen (PaO2)
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2018
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

CRISTINA EMBID LOPEZ

Principal Investigator

Hospital Clinic of Barcelona

Eligibility 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.

Outcomes

Primary Outcomes

Partial pressure of oxygen (PaO2)

Time Frame: two weeks

Measure levels after each polysomnography using arterial blood gases

Partial pressure of carbon dioxide (PaCO2)

Time Frame: two weeks

Measure levels after each polysomnography using arterial blood gases

Secondary Outcomes

  • Oxygen saving time below 90% (CT90%)(one month)

Study Sites (1)

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