- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991535
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
March 19, 2024 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).
Study Type
Interventional
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
-
-
-
Barcelona, Spain, 08025
- Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
-
Contact:
- Pedro A Anton Albisu, Medical Dr
- Phone Number: 5972 +034935575972
- Email: PAnton@santpau.cat
-
Contact:
- Patricia Peñacoba Toribio, Physician
- Phone Number: 5972 +034935575972
- Email: PPenacoba@santpau.cat
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Sub-Investigator:
- Patricia Peñacoba Toribio, Physician
-
Principal Investigator:
- Pedro A Anton Albisu, Medical Dr
-
-
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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).
- Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.
- Clinically stable (within the previous month).
- Patients without previous NonInvasive Mechanical Ventilation treatment.
Exclusion Criteria:
- Clinical exacerbation.
- Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio < 70% or Sleep Apnea-Hypopnea Syndrome
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: Other
- Allocation: N/A
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transcutaneous carbon dioxide measurement
Time Frame: One hour
|
One hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inspiratory-time/total-respiratory-cycle value
Time Frame: One hour
|
One hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pedro A Anton Albisu, Medical Dr, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
- Study Chair: Patricia Peñacoba Toribio, Physician, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
- Study Chair: Macarena Segura, Physiotherapist, Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau
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
Primary Completion (Estimated)
December 1, 2016
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimated)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Overnutrition
- Nutrition Disorders
- Overweight
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Respiratory Insufficiency
- Obesity
- Sleep Apnea, Obstructive
- Hypoventilation
- Obesity Hypoventilation Syndrome
- Neuromuscular Diseases
Other Study ID Numbers
- IIBSP-VEN-2013-23
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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