Perioperative Predictive Value of Physical Activity on Short- and Long-term Morbidity and Mortality (PeriopPrePA)
Over 300 million surgeries are performed globally every year. Complications after surgery - infections, cardiovascular conditions, postoperative pulmonary complications and renal impairment - affect survival and quality of life.
Age and co-morbidity are unmodifiable factors, contributing to increased risk of these perioperative complications. However, a modifiable risk factor is physical activity. This study aims to test if self reported physical activity has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Research question: This cohort study investigates if higher levels of self reported physical activity at preoperative assessment has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Background: Previous studies of perioperative outcomes in high-income countries indicate that close to 20% had complications within 30 days after surgery, and that around 3% died within 1 yr after surgery. In multiple studies, postoperative complications massively increase risk of 1yr mortality. Whilst perioperative complications are under-reported, they affect length of stay and days at home up to 30 days after surgery (DAH30). DAH30 is a validated, patient-centered outcome measure with prognostic importance due to high sensitivity to changes in surgical risks and the impact of surgical complications. DAH365, the days at home up to one year after surgery, is also an important patient-centered outcome measure.
Data collection: Age, sex, body mass index, co-morbid conditions (using ICD-codes and reported medication) as well as American Society of Anesthesiologists (ASA) physical status classification will be recorded. The predictor of interest: the Metabolic Equivalent of Task Score (MET-score), reported in the electronic health record by the attending anesthesiologist based on patient history in conjunction with the preoperative assessment.
Analysis: The MET-score is the predictor of interest. The potential added predictive value of the MET-score, will be assed using a machine learning approach, by comparing it to other established predictive factors.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Max Bell, MD, PhD
- Numero di telefono: +46708278533
- Email: max.bell@regionstockholm.se
Backup dei contatti dello studio
- Nome: Arman Valadkhani, MD, PhD
- Numero di telefono: +46812370000
- Email: arman.valadkhani@regionstockholm.se
Luoghi di studio
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Stockholm, Svezia
- Reclutamento
- Karolinska Institutet
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Contatto:
- Max Bell, MD, PhD
- Email: max.bell@regionstockholm.se
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Investigatore principale:
- Max Bell, MD, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery at the two study sites, Karolinska University Hospital Solna and Karolinska University Hospital Huddinge
Exclusion Criteria:
- Patients under the age of 18, transplant, day surgery, acute surgery, anesthesia monitoring, brachy therapy and gamma knife interventions. In case of multiple surgeries, only the first will be included.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Mortality
Lasso di tempo: [Time Frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery]
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Death within the time frames described below
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[Time Frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery]
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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DAH30 (Days At Home alive at 30 days)
Lasso di tempo: 30 days after index surgery
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DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16.
Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14.
Anyone who dies within 30 days will have DAH30=0.
This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS).
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30 days after index surgery
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DAH365 (Days At Home alive at 365 days)
Lasso di tempo: 365 days after index surgery
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DAH365: See above
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365 days after index surgery
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- PeriopPrePA Karolinska
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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