Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation (IMHUNIV)
14. marts 2019 opdateret af: ADIR Association
Protocol Summary:
- Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions?
- Aims
Main aim:
The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning.
Second aims:
The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence.
Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system.
The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital.
It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them.
At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit.
Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done.
During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by:
- polysomnography (only during the first night)
- transcutaneous capnography
- accessory inspiratory muscles surface electromyography
- pneumotachograph on non invasive ventilation's circuit
- pressions measured at the mask.
Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bois-Guillaume, Frankrig, 76230
- ADIR Association
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Type 2 chronic respiratory failure (PaCO2 > 6,5 at the time of the diagnosis)
- Indication of a long term non invasive ventilation at home because of an obstructive respiratory disease, a obesity hypoventilation syndrome or a neuromuscular disease.
- Over eighteen years old
- Planned hospitalisation to introduce non invasive ventilation.
Exclusion Criteria:
- Less than eighteen years old
- Pregnancy
- Psychiatric or cognitive disorders in wich consent is not possible
- Acute respiratory failure within 2 weeks before inclusion.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Befugtning
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Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.
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Ingen indgriben: Control group without humidification
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in sleep quality at two month
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Sleep quality will be assessed by polysomnography without non invasive ventilation at Baseline versus with non invasive ventilation at follow up with or without humification (after 2month)
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective sleep quality
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed using the Pittsburgh sleep quality index.
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval.
The measure consists of nineteen individual items, creating seven components which are summed to produce a global score.
Each component ranges from zero to three (zero: no difficulty at all ; three: great difficulties).
Global score ranges from zero (no difficulty) to twenty-one points (great difficulties).
|
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Nature of patient-ventilator asynchrony
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed by two independent investigators through raw data from the ventilator
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Number of patient-ventilator asynchrony
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
Outcome will be assessed by two independent investigators through raw data from the ventilator
|
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
|
Comfort with non invasive ventilation
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed using a visual analogic scale ranging from zero to ten (zero: very uncomfortable ; ten: greater comfort).
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Nasal obstruction
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed using the Nasal Obstruction Symptom Evaluation questionary (NOSE) which is an instrument allowing clinicians to better understand impact of nasal obstruction on patients' quality of life.
The measure consists of five individual items evaluated on a one-month past interval.
Each item ranges from zero (not a problem) to four (severe problem).
Then, scores are summed to create a global score ranging from zero (not a problem) to twenty (severe problem).
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Rhinorrhea and xerostomia
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcomes will be assessed using visual analogic scale ranging from zero to ten (zero: no rhinorrhea or xerostomia at all ; ten: worse rhinorrhea or xerostomia).
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Quality of life: Severe Inspirator Insufficiency questionary
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed using the Severe Inspirator Insufficiency questionary.
It's a specific instrument for measuring health-related quality of life in patients receiving home mechanical ventilation.
The measure consists of forty-nine individual items, creating seven components which are summed to produce a global score.
Each item ranges from one to five (one: not true ; five: very true).
Each component ranges from zero to one hundred.
Global score is the seven components' mean.
It ranges from zero (bad quality of life) to one hundred percent (best quality of life).
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Number of nightime disruption of non invasive ventilation
Tidsramme: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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Outcome will be assessed using raw data from the ventilator.
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Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
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Adherence
Tidsramme: Outcome will be assessed at study completion (two months follow-up).
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Number of hours of treatment by night
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Outcome will be assessed at study completion (two months follow-up).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Antoine Cuvelier, Prof, PhD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
- Ledende efterforsker: Maxime Patout, MD, MsC, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
- Ledende efterforsker: Astrid Bertier, MD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. maj 2018
Primær færdiggørelse (Faktiske)
14. marts 2019
Studieafslutning (Faktiske)
14. marts 2019
Datoer for studieregistrering
Først indsendt
18. maj 2018
Først indsendt, der opfyldte QC-kriterier
18. juni 2018
Først opslået (Faktiske)
19. juni 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IMHUNIV
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