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Patients-ventilator Interaction During Sleep: Effect of Humidification System

Primary Purpose

Chronic Hypercapnic Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
heated humidification
heat and moisture exchanger
usual mechanical ventilation without humidification
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Hypercapnic Respiratory Failure focused on measuring chronic hypercapnic respiratory failure, COPD, RTD, sleep architecture, humidification

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione S.Maugeri

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

usual ventilation

heated humidifier

heat and moisture exchanger

Arm Description

application of usual mechanical ventilation without humidification system

mechanical ventilation with heated humidifier

mechanical ventilation with heat and moisture exchanger

Outcomes

Primary Outcome Measures

sleep quality and asynchrony index

Secondary Outcome Measures

tolerance assessed using an ad-hoc designed scale (1 t0 5 scale), and the effective hours of sleep

Full Information

First Posted
December 16, 2009
Last Updated
October 8, 2014
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01038791
Brief Title
Patients-ventilator Interaction During Sleep: Effect of Humidification System
Official Title
Patients-ventilator Interaction During Sleep: the Role of Humidification. A Pilot Short Term Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
BACKGROUND Non-invasive mechanical ventilation (NIMV), usually delivered during night time, is widely used at home in chronic hypercapnic respiratory, both in patients with COPD and restrictive thoracic diseases (RTD). The aim of chronic NIMV is to improve daytime arterial blood gases, sleep quality decreasing symptoms of hypoventilation (mainly during sleep), quality of life and mood. Scarce data is available about the NIMV compliance at home; poor compliance may reduce the positive effects of mechanical ventilation. Previous data shows that patients enrolled to long-term home ventilation program may drop out early, mainly because of skin irritation, upper airway problems, and air leaks. Studies performed on patients with sleep apnea, receiving CPAP therapy at home, showed that the occurrence of leaks during ventilation can cause the development of mucosal inflammation, nasal congestion and increased nasal airways resistance. On the other hand, the presence or the development of nasal obstruction makes the arise or the worsening of air leaks (the vicious cycle) more reliable. A lack of humidification may increase nasal resistance and nasal symptoms and, therefore, contribute to reduction in compliance. Furthermore, leaks may have significant consequences on inspiratory and expiratory trigger functions, inducing poor patient-ventilator interactions. Indeed, the presence of ineffective efforts, the most common phenomenon of bad patient-ventilation interactions, is very common in patients receiving long term home ventilation and usually associated with poorer gas exchange during sleep. 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. PATIENTS We plan to enrol 20 patients with chronic respiratory failure or sleep hypoventilation already included in a long-term home non-invasive ventilation program (at least 3 months). 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. Exclusions 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. STUDY DESIGN Patients will undergo three consecutive nocturnal polysomnographs. Patients will have a baseline therapy of NIMV without humidification for 1 week. They will then undergo a nocturnal polysomnograph on the last evening of the baseline therapy. Patients will then be randomly assigned to use HH or HME for 1 week and undergo a nocturnal polysomnography on the last evening . The patients will then be assigned to the second method of humidification for 1 week and undergo a third nocturnal polysomnograph on the last evening. The whole evaluation will be performed with the same ventilator (ideally the patient's device) using the patient's mask and with the usual ventilator setting. Measures At enrolment: Lung function test Standard questionnaire about the use and tolerability of NIMV at home Measure of NIMV compliance at home Blood gas analysis during wakefulness (during spontaneous breathing - SB - and during NIMV) The breathing pattern during wakefulness (during SB and NIMV) Polysomnographic evaluation Full standard assisted polysomnography with simultaneous recordings of Tidal Volume, Leaks, pressure in mask, respiratory rate, instantaneous minute ventilation. Analysis of sleep data will be performed according to standard criteria (AASM 2007). Analysis of breathing pattern and patients-ventilator interaction will be made according to previous published methods (Fanfulla, Tuggey, Techsler etc..). At the end of the each PSG recording, patients will be asked about their humidification and NIMV tolerance as well as the presence of upper airway symptoms (Nava et al).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hypercapnic Respiratory Failure
Keywords
chronic hypercapnic respiratory failure, COPD, RTD, sleep architecture, humidification

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual ventilation
Arm Type
Active Comparator
Arm Description
application of usual mechanical ventilation without humidification system
Arm Title
heated humidifier
Arm Type
Experimental
Arm Description
mechanical ventilation with heated humidifier
Arm Title
heat and moisture exchanger
Arm Type
Experimental
Arm Description
mechanical ventilation with heat and moisture exchanger
Intervention Type
Device
Intervention Name(s)
heated humidification
Other Intervention Name(s)
HH
Intervention Description
temperature 35°
Intervention Type
Device
Intervention Name(s)
heat and moisture exchanger
Other Intervention Name(s)
HME
Intervention Description
single patient device
Intervention Type
Device
Intervention Name(s)
usual mechanical ventilation without humidification
Other Intervention Name(s)
control
Intervention Description
mechanical ventilation with usual parameters
Primary Outcome Measure Information:
Title
sleep quality and asynchrony index
Time Frame
8 hrs
Secondary Outcome Measure Information:
Title
tolerance assessed using an ad-hoc designed scale (1 t0 5 scale), and the effective hours of sleep
Time Frame
8 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Fanfulla, MD
Organizational Affiliation
Fondazione S.Maugeri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione S.Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18669787
Citation
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.
Results Reference
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Patients-ventilator Interaction During Sleep: Effect of Humidification System

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