Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation (IMHUNIV)
14 maart 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bois-Guillaume, Frankrijk, 76230
- ADIR Association
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Bevochtiging
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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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Geen tussenkomst: Control group without humidification
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline in sleep quality at two month
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Subjective sleep quality
Tijdsspanne: 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).
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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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Nature of patient-ventilator asynchrony
Tijdsspanne: 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
Tijdsspanne: 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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Comfort with non invasive ventilation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: 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
- Hoofdonderzoeker: 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
- Hoofdonderzoeker: 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
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 mei 2018
Primaire voltooiing (Werkelijk)
14 maart 2019
Studie voltooiing (Werkelijk)
14 maart 2019
Studieregistratiedata
Eerst ingediend
18 mei 2018
Eerst ingediend dat voldeed aan de QC-criteria
18 juni 2018
Eerst geplaatst (Werkelijk)
19 juni 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
14 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IMHUNIV
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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