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NCT Number: NCT03152734

Periinterventional Outcome Study in the Elderly

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

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Key information

Conditions

Mortality Complication, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Salzburg, Salzburg, Austria

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About this study

Elderly population (≥80 years) will increase from 5.3% of the total population in 2015 to 9% in 2040. This implies an increasing number and variety of surgical and non-surgical interventional procedures. Little is known about the in-hospital mortality rates in the overall elderly interventional population. Compared with younger interventional patients, the elderly are at greater risk of peri-interventional mortality and morbidity, because of decline in physiological and cognitive reserve, and frequent comorbidities. Previous data are mostly limited to specific populations, like the elderly hip fracture patient.

The investigators aim to recruit as many as possible centers throughout Europe, to participate in this study. A total sample size of 7500 patients will provide reasonable and valid results for the study aims. The primary endpoint will be analysed by fitting a COX-Regression model to the data of the post-interventional mortality until day 30.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 80 years
  • Written informed consent according to the national law requirements
  • All consecutive patients undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (done by an anaesthetist) within the selected inclusion period of four weeks
  • Elective and emergency procedures
  • In-patient and out-patient procedures

Exclusion criteria

  • People who are institutionalized by court or administrative order
  • Patients with re-intervention within the 4 week period, who were already enrolled in this study

Treatment and study plan

Surgical or non-surgical intervention

Procedure

Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist

Primary outcomes

  1. Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30

    Time frame: From intervention until day 30.

    Number of patients with death from any cause

Secondary outcomes

  1. In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)

    Time frame: From intervention until day 30.

    Number of patients with e.g. pneumonia, cardiovascular complication, surgical site infection, urinary tract infection, venous thromboembolism, acute or progressive renal failure and re-surgery

  2. Analysis of the new-onset of serious cardiac complications

    Time frame: From intervention up to 30-days after intervention

    Number of patients with serious cardiac complication

    Cardiac complication is defined according to the American Heart Association

  3. Analysis of the new-onset of serious pulmonary complications

    Time frame: From intervention up to 30-days after intervention

    Number of patients with

    • Pneumonia: Clinical or radiological diagnosis. or
    • Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy

  4. Analysis of the new-onset of acute stroke

    Time frame: From intervention up to 30-days after intervention

    Number of patients with new-onset of acute stroke, defined as a new focal or generalised neurological deficit of >24h duration in motor, sensory, or coordination functions with compatible brain imaging and confirmed by a neurologist. Transient ischemic attack is not considered as acute stroke. Signs of stroke in the autopsy.

  5. Analysis of the new-onset of acute kidney injury

    Time frame: From intervention up to 30-days after intervention

    Number of patients with new-onset of acute kidney injury, defined according to the AKIN classification as AKI stage ≥2.

    This means increase of creatinine >2-3x from baseline within the hospital stay. Or urine output less than 0.5 ml kg-1 per hour for more than 12 hours. Or signs of acute kidney injury in the autopsy.

  6. Unplanned intensive care unit admission

    Time frame: From intervention until hospital discharge or maximum 30-days after intervention

    Number of patients

  7. Unplanned intubation after intervention

    Time frame: From intervention until hospital discharge or maximum 30-days after intervention

    Number of patients

  8. Hospital discharge destination

    Time frame: From intervention until hospital discharge or maximum 30-days after intervention

    Number of patients, who are not discharged, discharged home, discharged to rehabilitation, discharged to other hospital, discharged to a nursing home, diseased in hospital or discharged to another destination, respectively.

  9. Perioperative admission to a unit with a geriatric care model

    Time frame: From intervention until hospital discharge or maximum 30-days after intervention

    Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services

  10. Patient's functional status of independency

    Time frame: On day 30 after intervention

    Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent).

  11. Brief screen for cognitive impairment

    Time frame: On day 30 after intervention

    Number of correct recall of three words (Brief Screen for Cognitive Impairment test)

  12. Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries

    Time frame: On day 30 after intervention

    Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient

  13. Number of used intra-interventional monitoring for elderly patients in the clinical routine

    Time frame: Intra-interventional

    Number of patients, where a specific monitoring device was intra-interventionally used

  14. Number of patients with premedication

    Time frame: Intra-interventional

    Number of patients with premedication given before intervention.

  15. Type of anesthesia technique

    Time frame: Intra-interventional

    Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)

  16. Type of the main anesthetic

    Time frame: Intra-interventional

    Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)

  17. Type of the main intra-interventional opioid

    Time frame: Intra-interventional

    Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.)

  18. Anesthesia duration

    Time frame: Intra-interventional

    Begin to end of anesthesia for intervention

  19. Amount of intra-interventionally transfused blood and blood products

    Time frame: Intra-interventional

    e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets

  20. Number of extubated patients

    Time frame: Intra-interventional

    At the end of intervention

  21. Kind of intervention

    Time frame: Intra-interventional

    Surgical procedure category, severity, urgency, wound class

  22. Use of WHO safe surgery checklist

    Time frame: Intra-interventional

    Number of patients , where the WHO safe surgery checklist was used

  23. Kind of referring facility

    Time frame: Pre-interventional at baseline visit

    Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively.

  24. Amount of pre-interventional comorbidities

    Time frame: pre-interventional at baseline visit

    Number of comorbidities

  25. Albumin and hematocrit level before intervention

    Time frame: pre-interventional at baseline visit

    Optional assessment, only if done in the clinical routine

  26. Number of falls in the last 6 months

    Time frame: pre-interventional at baseline visit

    Number of falls per patient

  27. Mini-Cog (for the cognitive status)

    Time frame: pre-interventional at baseline visit

    Performance of the mini-cog test and analysis of the maximum points in this test

  28. Pre-interventional timed "Up & Go" test

    Time frame: pre-interventional at baseline visit

    Seconds to perform the up and go test will be measured

  29. Comparison of the patients' outcomes across Europe

    Time frame: 30 days after intervention

    Comparing the number of adverse outcomes between the hospitals and countries

Other outcomes

  1. Age and gender-effect on the 30 day mortality

    Time frame: 30 days after intervention

    Association of patient age/ gender and mortality

  2. Effect of pre-interventional morbidities on the 30 day mortality

    Time frame: 30 days after intervention

    Association of pre-operative morbidities and mortality

  3. Effect of type of surgery or non-surgical intervention on the 30 day mortality

    Time frame: 30 days after intervention

    Association of type of surgery or non-surgical intervention and mortality

  4. Effect of centre and country on the 30 day mortality

    Time frame: 30 days after intervention

    Association of center/ country and mortality

  5. In-hospital cardiopulmonary resuscitation

    Time frame: From intervention until hospital discharge or maximum 30-days after intervention

    Rate

Sponsors and collaborators

Lead sponsor

Mark Coburn

Other

Registry information

Official study title

Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

Acronym: POSE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 15, 2017
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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