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Patients-ventilator Interaction During Sleep: Effect of Humidification System

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ClinicalTrials.gov Identifier: NCT01038791
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
dr. Stefano Nava, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Brief 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.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : December 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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.

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

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 Posted: December 24, 2009    Key Record Dates
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