Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

NCT01991535 | Withdrawn

• 1 other identifier: IIBSP-VEN-2013-23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Disorders; Chest Wall Disorders; Obesity Hypoventilation Syndrome (OHS)

Outcome Measures

Primary Outcomes (1)

• Transcutaneous carbon dioxide measurement

  One hour

Secondary Outcomes (1)

• Inspiratory-time/total-respiratory-cycle value

  One hour

Interventions

Spontaneous Ventilation Mode DEVICE

Respiratory rate and duration of inspiration are controlled by the patient. Device model: Stellar 150® (ResMed, Australia).

Controlled Ventilation Mode DEVICE

Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles. Device model: Stellar 150® (ResMed, Australia).

Simulator Ventilation Mode DEVICE

Ventilator maintains a continuous positive airway pressure during the entire cycle. Device model: Stellar 150® (ResMed, Australia).

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Clinical exacerbation.
• Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio \< 70% or Sleep Apnea-Hypopnea Syndrome

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pedro A Anton Albisu, Medical Dr

  Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Primary Completion: December 1, 2016
• Last Updated: March 21, 2024

Record last verified: 2015-10

Locations

ES (1)