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Patients-ventilator Interaction During Sleep: Effect of Humidification System

This study is currently recruiting participants.
Verified January 2013 by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01038791
First received: December 16, 2009
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • sleep quality and asynchrony index [ Time Frame: 8 hrs ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038791

Contacts
Contact: Francesco fanfulla, MD 390382592807 francesco.fanfulla@fsm.it

Locations
Italy
Fondazione S.Maugeri Recruiting
Pavia, Italy, 27100
Contact: Francesco Fanfulla, MD     390382592807     francesco.fanfulla@fsm.it    
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
Study First Received: December 16, 2009
Last Updated: January 25, 2013
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013