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Patients-ventilator Interaction During Sleep: Effect of Humidification System

NCT01038791 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-10-09

No results posted yet for this study

Summary

At present, little data is available in the medical literature regarding the affects of humidification on NIMV efficacy, sleep quality and upper airway symptoms in patients undergoing nocturnal NIMV.

The aim of the present pilot study is to assess the impact of two humidification systems on sleep quality, NIMV efficacy, patient-ventilator interaction, prevalence of NIMV side effects, compliance to treatment, in a group of stable patients already enrolled in a long-term nocturnal mechanical ventilation program for chronic hypercapnic respiratory failure or sleep hypoventilation.

Conditions

  • Chronic Hypercapnic Respiratory Failure

Interventions

DEVICE

heated humidification

temperature 35°

DEVICE

heat and moisture exchanger

single patient device

DEVICE

usual mechanical ventilation without humidification

mechanical ventilation with usual parameters

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Francesco Fanfulla, MD · Fondazione S.Maugeri

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038791 on ClinicalTrials.gov