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Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Intensive Care Unit (ICU)

5. august 2019 opdateret af: Tufts Medical Center

Effects Of Invasive And Noninvasive Mechanical Ventilation On Sleep In The Icu

The purpose of this study is to monitor sleep in patients using breathing machines, because little is known about sleep when patients use masks to help their breathing. We'd like to compare sleep in patients using masks to that in patients with a tube in their throats.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Sleep in critically-ill patients is commonly severely fragmented, and sleep architecture is altered as compared to a healthy person. This abnormal sleep may cause some important adverse psychological and physiological consequences. Noise, light, patient-care activities, pain, or medications are some of the contributing factors to sleep disruption in the ICU. Recent evidence also suggests that invasive mechanical ventilation (IMV) itself may lead to sleep fragmentation in the ICU. Noninvasive ventilation (NIV) is a well-established, relatively new form of ventilation which improves sleep quality or gas exchange in some patients with chronic hypoventilatory disorders. Although sleep may be disrupted due to discomfort from the mask or air leaking during NIV use; intermittent use of NIV may result in better sleep quality between NIV sessions. The effects of NIV on sleep in the acute care setting have not yet been studied.

The purpose of the study is to describe the sleep architecture of a cohort of critically-ill patients using NIV, comparing findings to a reference group of patients using (IMV).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

16

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts-New England Medical Center Medical ICU and Coronary Care Unit

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Critically ill patients undergoing invasive or noninvasive mechanical ventilation in medical ICU and CCU at Tufts New England Medical Center

Beskrivelse

Inclusion Criteria:

  • Age > 18 yrs
  • Receiving invasive or noninvasive mechanical ventilation
  • Anticipated further ventilation of at least 24-hour duration for IMV and 8 hours/ 24 hours for NIV

Exclusion Criteria:

  • Pre-morbid diseases that could interfere with interpretation of sleep monitoring including CNS disorders (strokes, encephalopathic states), dementia, and known sleep disorders
  • On home BiPAP or CPAP
  • Depressed sensorium as evidence by Glasgow Coma Score < 10, need for continuous sedation with Riker Score < 2 and inability to follow verbal commands for sustained 3 hours
  • Presence of head trauma, psychiatric illness (including use of antidepressant medication), anoxic brain injury, drug overdose or uncontrolled seizure disorder
  • Severe hemodynamic instability (BP< 90 mmHg despite vasopressor therapy) and sepsis
  • Recalcitrant hypoxemia (inability to sustain SaO2 > 88%)
  • Considered as unstable by ICU team (hemodynamic instability, acute uncontrolled GI bleeding, acute cardiac ischemia or arrhythmias)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
1
critically ill patients undergoing invasive mechanical ventilation in medical ICU and CCU
2
critically ill patients undergoing noninvasive mechanical ventilation in medical ICU and CCU

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To define sleep characteristics in critically-ill patients receiving mechanical ventilation in medical ICU and coronary care unit (CCU)
Tidsramme: During 24-hour monitorization period (after recruitment into the study)
During 24-hour monitorization period (after recruitment into the study)

Sekundære resultatmål

Resultatmål
Tidsramme
To compare total sleep time and differences in sleep architecture including time spent in different sleep stages and arousals in critically-ill patients receiving mechanical ventilation in medical ICU and CCU
Tidsramme: During 24-hour monitorization
During 24-hour monitorization
To determine sleep patterns during NIV use, correlating sleep with periods of use and air leaking
Tidsramme: During 24-hour monitorization
During 24-hour monitorization
To monitor environmental factors including noise, light and patient care activities, and to associate these with sleep patterns
Tidsramme: During 24-hour monitorization
During 24-hour monitorization
To assess associations of severity of illness and sedation usage with sleep patterns
Tidsramme: During 24-hour monitorization period
During 24-hour monitorization period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tufts Medical Center

Efterforskere

  • Studieleder: Aylin Ozsancak, MD, Research Fellow
  • Ledende efterforsker: Nicholas S Hill, MD, Chair of Pulmonary, Critical Care and Sleep Medicine Division

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)

1. november 2006

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. marts 2017

Datoer for studieregistrering

Først indsendt

12. marts 2008

Først indsendt, der opfyldte QC-kriterier

18. marts 2008

Først opslået (Skøn)

19. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-8053

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Betingelser

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Placeringer

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