Patients-ventilator Interaction During Sleep: Effect of Humidification System

NCT ID: NCT01038791

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2014-06-30

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).

Conditions

Chronic Hypercapnic Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

usual ventilation

application of usual mechanical ventilation without humidification system

Group Type: ACTIVE_COMPARATOR

usual mechanical ventilation without humidification

Intervention Type: DEVICE

mechanical ventilation with usual parameters

heated humidifier

mechanical ventilation with heated humidifier

Group Type: EXPERIMENTAL

heated humidification

Intervention Type: DEVICE

temperature 35°

heat and moisture exchanger

mechanical ventilation with heat and moisture exchanger

Group Type: EXPERIMENTAL

heat and moisture exchanger

Intervention Type: DEVICE

single patient device

Interventions

heated humidification

temperature 35°

Intervention Type: DEVICE

heat and moisture exchanger

single patient device

Intervention Type: DEVICE

usual mechanical ventilation without humidification

mechanical ventilation with usual parameters

Intervention Type: DEVICE

Other Intervention Names

HH; HME; control

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

dr. Stefano Nava

Chief ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Fanfulla, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione S.Maugeri

Locations

Fondazione S.Maugeri

Pavia, Pavia, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 18669787 (View on PubMed)

Other Identifiers

593

Identifier Type: -

Identifier Source: org_study_id