Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Obstructive Sleep Apnea in Elective Orthopaedic Surgery

8. marts 2018 opdateret af: Victor Hugo Hernandez, University of Miami

Effects of Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing steadily and is projected to continue trending upwards in the coming years. Concomitant with that trend is the increase in prevalence of obesity. Obesity serves as a common risk factor for osteoarthritis, obstructive sleep apnea and medical complications.

Obstructive Sleep Apnea (OSA) is defined as episodes of obstructive apneas and hypopneas during sleep, with daytime somnolence. It occurs commonly in obese, middle age and elderly men and has an estimated prevalence of 5% - 9%.

Pre-operative screening for elective surgical procedures is a critical component of a successful surgical outcome. Patients with medical comorbidities ideally will undergo medical treatment or optimization to minimize the risk peri-operatively and post-operatively. Obstructive sleep apnea has been shown in numerous studies to be a risk factor for cardiopulmonary complications following surgery. The contributing factors include alterations in REM sleep post-operatively and opioid induced respiratory suppression post-operatively.

The STOP-BANG patient questionnaire is a validated patient survey that uses both objective and subjective data to screen patients for their risk of OSA. The sensitivity of the STOP-BANG questionnaire for moderate-to-severe OSA has been estimated as high as 97.74%. Authors have also shown that higher STOP-BANG scores are independently associated with increased risk for post-operative complication.

Other authors have utilized similar pre-operative questionnaires to screen for occult pulmonary disease in patients scheduled for elective joint arthroplasty. They found a slightly increased incidence of OSA in this population as compared with the national average, over 50% of which were previously undiagnosed.

The American Society of Anesthesiologists task force on perioperative management of patients with OSA published extensive guidelines aimed at reducing morbidity and mortality. Improved diagnosis pre-operatively could aid in proper compliance with these guidelines. These recommendations include preferential use of regional analgesia, reduction in systemic opioids, monitoring of oxygen saturation and nonsupine posture.

The mainstay of treatment for OSA is a positive pressure airway device such as Continuous Positive Airway Pressure (CPAP) or in severe cases Nasal Intermittent Positive Pressure Ventilation (NIPPV). Post-operatively continuation of these treatments in patients with known OSA is often recommended. Some authors have demonstrated reductions in Apnea-Hypopnea Index postoperatively through the use of CPAP.

However, a recent meta-analysis evaluating the effect of pre-operative or post-operative CPAP in patients with OSA concluded that the use of CPAP did not reduce post-operative adverse events.

Given the projected increase in demand for joint arthroplasty, the ever-increasing incidence of obesity, the ambiguity surrounding the topic and the potential to clinically impact post-operative morbidity, mortality and health care costs, shows the need for further studies.

Studieoversigt

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Hospital

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:

  • > 18 years of age
  • Have signed the written informed consent form
  • STOP-BANG score greater than or equal to 5

Exclusion Criteria:

  • Patients not fluent in the language of the informed consent form (English, Spanish, Creole)
  • Prisoners
  • Pregnancy
  • Reported to have mental illness or belonging to a vulnerable population
  • Patients with previous diagnosis and treatment of Obstructive sleep apnea

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Patients in this arm will proceed through the current standard of care for pre-operative screening performed by either the patient's primary care physician or the "pre-operative" anesthesia clinic which screens patients prior to total knee or total hip arthroplasty.
Eksperimentel: Intervention
Patients in this arm will be referred to the Sleep Medicine clinic at the University of Miami Hospital for additional testing and evaluation for obstructive sleep apnea. If they are successfully diagnosed, they will receive appropriate treatment and any interventions for the peri-operative period as recommended by the pulmonary medicine team.
Patients randomized to the intervention arm will be referred to the sleep medicine specialists for evaluation. All of their recommendations will be followed if indicated.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post Operative Complications both acute and short term
Tidsramme: 90 days
The investigators will assess if screening and subsequent treatment for obstructive sleep apnea reduces the incidence of unplanned admission to the intensive care unit, post operative delirium, post operative hypoxia necessitating supplemental oxygen, myocardial infarction as measured by objective measures such as troponin levels and EKG changes and thromboembolism. The incidence of any one of these factors is relatively low. Therefore the investigators will aggregate them as the number of subjects needed to asses them individually would be too large.
90 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Financial Impact
Tidsramme: 90 days
Readmission Rate
90 days
Financial Impact
Tidsramme: 30 days
Length of inpatient stay postoperatively
30 days
Financial Impact
Tidsramme: 90 days
Discharge location: Home versus skilled nursing facility versus inpatient rehabilitation versus long term care facility versus other
90 days
Functional Outcomes
Tidsramme: 90 days
Oxford Hip/Knee Score measured in units of the scale
90 days
Functional Outcomes
Tidsramme: 90 days
Western Ontario and McMaster Universities Arthritis Index measured in units of the scale, WOMAC
90 days
Functional Outcomes
Tidsramme: 90 days
Harris Hip/Knee Score measured in units of the scale
90 days

Samarbejdspartnere og efterforskere

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

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)

8. februar 2018

Primær færdiggørelse (Forventet)

8. februar 2018

Studieafslutning (Forventet)

8. februar 2018

Datoer for studieregistrering

Først indsendt

7. september 2016

Først indsendt, der opfyldte QC-kriterier

23. maj 2017

Først opslået (Faktiske)

25. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvnapnø, obstruktiv

Kliniske forsøg med Evaluation by Sleep Medicine Specialists

Abonner