Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation (IMHUNIV)
14 marzo 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bois-Guillaume, Francia, 76230
- ADIR Association
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Umidificazione
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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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Nessun intervento: Control group without humidification
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in sleep quality at two month
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective sleep quality
Lasso di tempo: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
Outcome will be assessed using raw data from the ventilator.
|
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
|
|
Adherence
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: 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
- Investigatore principale: 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
- Investigatore principale: 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
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
21 maggio 2018
Completamento primario (Effettivo)
14 marzo 2019
Completamento dello studio (Effettivo)
14 marzo 2019
Date di iscrizione allo studio
Primo inviato
18 maggio 2018
Primo inviato che soddisfa i criteri di controllo qualità
18 giugno 2018
Primo Inserito (Effettivo)
19 giugno 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 marzo 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 marzo 2019
Ultimo verificato
1 marzo 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IMHUNIV
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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