Unrecognised Obstructive Sleep Apnea Study (OSA)
25. januar 2018 oppdatert av: Dr. Frances Chung, University Health Network, Toronto
Postoperative Vascular Events in Unrecognised Obstructive Sleep Apnea
Plan of investigation:
This is an observational cohort study to determine the effect of OSA, independent of other risk factors, on postoperative vascular events. The study is conceived, designed and will be conducted, and analyzed independent to any company. There is no commercial sponsorship.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The potential study subjects will be approached by study coordinator at preoperative clinic.
If the patient is interested in participating the study, he/she will be screened and consented.
Undetected or untreated OSA will be established by STOP-Bang questionnaire and subsequent overnight PSG by using Apnea Link Plus which is level ( 2 ) at patient's home.The following data will be recorded: including age, gender, history of coronary artery disease, prior revascularization, cerebrovascular disease, peripheral vascular disease, critical aortic valvular stenosis, congestive heart failure, atrial fibrillation, diabetes treated with insulin or an oral diabetic drug, hypertension, hypercholesterolemia treated with drug therapy, tobacco use, renal insufficiency and the type of surgery.
For all study patients, the nocturnal blood oxygen saturation will be monitored by a pulse oximeter (PULSOX 300i) for first 3 nights postoperatively.During their stay in hospital, patients will be followed daily, and outcomes will be recorded, until discharge.. ECG will be measured preoperatively and repeated on day 1 to 3 after surgery.
Venous blood will be collected 6-12 hours and on the first 3 days after surgery for measuring cTnT concentration.If patient's ECG is abnormal and/or patient is positive for troponin test, treating physician will be contacted for further treatment.
Patient will be contacted 30 days after surgery by phone to ascertain if they have experienced any adverse out come.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Surgical patient
Beskrivelse
Patients Inclusion & Exclusion Criteria:
Inclusion criteria:
Ethics Committee approval and informed consent will be obtained. We plan to study patients at moderate-to-high risk for postoperative vascular complications because our data from other trials suggested that the incidence of OSA in these patients is higher than the general population. We will include patients who are:
- adult males and females, age ≥ 45 years, undergoing elective non-cardiac surgery that is expected to require a postoperative hospital stay of more than 3 nights, and
- at increased risk for postoperative vascular events, defined as having at least one of the following risk factors (a) high-risk surgery (intra-peritoneal, intra-thoracic or supra-inguinal vascular surgery); (b) history of ischemic heart disease; (c) history of congestive heart failure; (d) history of cerebrovascular disease (d) diabetes requiring insulin therapy (e) serum creatinine > 175 µmol/L.
Exclusion criteria:
Patients will be excluded if:
- they have a previous diagnosis of OSA or any sleep-related breathing disorder and on treatment
- they are unwilling or physically unavailable for PSG on any night before surgery;
- their surgery included tonsillectomy, septoplasty, uvuloplasty, pharyngoplasty, tracheostomy, or prolonged (> 48 hrs) postoperative mechanical ventilation of the lungs is anticipated. It is because these procedures/interventions are likely to cure or at least modify the severity of OSA.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
primary outcome of this study is postoperative vascular event within 30 days after surgery
Tidsramme: 30 days
|
30 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Frances Chung, MBBS, FRCPC, University Health Network, Toronto
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Chung F, Waseem R, Wang CY, Seet E, Suen C, Chan MTV; Postoperative Vascular Complications in Unrecognised Obstructive Sleep Apnea (POSA) Study Investigators. Preoperative oximetry-derived hypoxemia predicts postoperative cardiovascular events in surgical patients with unrecognized obstructive sleep apnea. J Clin Anesth. 2022 Jun;78:110653. doi: 10.1016/j.jclinane.2022.110653. Epub 2022 Feb 4.
- Seet E, Chung F, Wang CY, Tam S, Kumar CM, Ubeynarayana CU, Yim CC, Chew EFF, Lam CKM, Cheng BCP, Chan MTV. Association of Obstructive Sleep Apnea With Difficult Intubation: Prospective Multicenter Observational Cohort Study. Anesth Analg. 2021 Jul 1;133(1):196-204. doi: 10.1213/ANE.0000000000005479.
- Waseem R, Chan MTV, Wang CY, Seet E, Tam S, Loo SY, Lam CKM, Hui DS, Chung F. Diagnostic performance of the STOP-Bang questionnaire as a screening tool for obstructive sleep apnea in different ethnic groups. J Clin Sleep Med. 2021 Mar 1;17(3):521-532. doi: 10.5664/jcsm.8940.
- Chan MT, Wang CY, Seet E, Tam S, Lai HY, Walker S, Short TG, Halliwell R, Chung F; POSA Investigators. Postoperative vascular complications in unrecognised Obstructive Sleep apnoea (POSA) study protocol: an observational cohort study in moderate-to-high risk patients undergoing non-cardiac surgery. BMJ Open. 2014 Jan 9;4(1):e004097. doi: 10.1136/bmjopen-2013-004097.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. januar 2018
Studiet fullført (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først innsendt
12. desember 2011
Først innsendt som oppfylte QC-kriteriene
14. desember 2011
Først lagt ut (Anslag)
16. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Version Nov 14, 2011
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .