Patients-ventilator Interaction During Sleep: Effect of Humidification System
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 9, 2014
January 1, 2013
4.5 years
December 16, 2009
October 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sleep quality and asynchrony index
8 hrs
Secondary Outcomes (1)
tolerance assessed using an ad-hoc designed scale (1 t0 5 scale), and the effective hours of sleep
8 hrs
Study Arms (3)
usual ventilation
ACTIVE COMPARATORapplication of usual mechanical ventilation without humidification system
heated humidifier
EXPERIMENTALmechanical ventilation with heated humidifier
heat and moisture exchanger
EXPERIMENTALmechanical ventilation with heat and moisture exchanger
Interventions
mechanical ventilation with usual parameters
Eligibility Criteria
You may qualify if:
- Patients in stable conditions (no acute exacerbations in the 4 weeks before enrolment), well adapted to ventilation and without problems with the ventilation mask.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione S.Maugeri
Pavia, Pavia, 27100, Italy
Related Publications (1)
Nava S, Cirio S, Fanfulla F, Carlucci A, Navarra A, Negri A, Ceriana P. Comparison of two humidification systems for long-term noninvasive mechanical ventilation. Eur Respir J. 2008 Aug;32(2):460-4. doi: 10.1183/09031936.00000208.
PMID: 18669787BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Fanfulla, MD
Fondazione S.Maugeri
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief ICU
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 24, 2009
Study Start
December 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 9, 2014
Record last verified: 2013-01