Patients-ventilator Interaction During Sleep: Effect of Humidification System

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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

  Hide Detailed Description

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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014