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Patients-ventilator Interaction During Sleep: Effect of Humidification System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038791
First Posted: December 24, 2009
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
  Purpose

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.


Condition Intervention Phase
Chronic Hypercapnic Respiratory Failure Device: heated humidification Device: heat and moisture exchanger Device: usual mechanical ventilation without humidification Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Patients-ventilator Interaction During Sleep: the Role of Humidification. A Pilot Short Term Study

Resource links provided by NLM:


Further study details as provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • sleep quality and asynchrony index [ Time Frame: 8 hrs ]

Secondary Outcome Measures:
  • tolerance assessed using an ad-hoc designed scale (1 t0 5 scale), and the effective hours of sleep [ Time Frame: 8 hrs ]

Enrollment: 15
Study Start Date: December 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: usual ventilation
application of usual mechanical ventilation without humidification system
Device: usual mechanical ventilation without humidification
mechanical ventilation with usual parameters
Other Name: control
Experimental: heated humidifier
mechanical ventilation with heated humidifier
Device: heated humidification
temperature 35°
Other Name: HH
Experimental: heat and moisture exchanger
mechanical ventilation with heat and moisture exchanger
Device: heat and moisture exchanger
single patient device
Other Name: HME

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in stable conditions (no acute exacerbations in the 4 weeks before enrolment), well adapted to ventilation and without problems with the ventilation mask.

Exclusion Criteria:

  • Patients with acute respiratory failure, recent exacerbations, severe co-morbidities (i.e. hearth failure, recent stroke etc.)
  • Recent upper airways surgery.
  • Allergic rhinitis, severe nasal stenosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038791


Locations
Italy
Fondazione S.Maugeri
Pavia, Italy, 27100
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Principal Investigator: Francesco Fanfulla, MD Fondazione S.Maugeri
  More Information

Publications:
Responsible Party: dr. Stefano Nava, Chief ICU, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT01038791     History of Changes
Other Study ID Numbers: 593
First Submitted: December 16, 2009
First Posted: December 24, 2009
Last Update Posted: October 9, 2014
Last Verified: January 2013

Keywords provided by dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
chronic hypercapnic respiratory failure
COPD
RTD
sleep architecture
humidification

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms