Periinterventional Outcome Study in the Elderly (POSE)

• ClinicalTrials.gov Identifier: NCT03152734
• Recruitment Status: Completed
• First Posted: May 15, 2017
• Last Update Posted: November 20, 2019
• Sponsor: Mark Coburn
• Information provided by (Responsible Party): Mark Coburn, RWTH Aachen University

Tracking Information

• First Submitted Date: May 9, 2017
• First Posted Date: May 15, 2017
• Last Update Posted Date: November 20, 2019
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: January 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 11, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 11, 2017)

• 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
• 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
• 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
• 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.
• 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.
• Unplanned intensive care unit admission [ Time Frame: From intervention until hospital discharge or maximum 30-days after intervention ]
  Number of patients
• Unplanned intubation after intervention [ Time Frame: From intervention until hospital discharge or maximum 30-days after intervention ]
  Number of patients
• 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.
• 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
• 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).
• 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)
• 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
• 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
• Number of patients with premedication [ Time Frame: Intra-interventional ]
  Number of patients with premedication given before intervention.
• Type of anesthesia technique [ Time Frame: Intra-interventional ]
  Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc)
• Type of the main anesthetic [ Time Frame: Intra-interventional ]
  Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.)
• 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.)
• Anesthesia duration [ Time Frame: Intra-interventional ]
  Begin to end of anesthesia for intervention
• 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
• Number of extubated patients [ Time Frame: Intra-interventional ]
  At the end of intervention
• Kind of intervention [ Time Frame: Intra-interventional ]
  Surgical procedure category, severity, urgency, wound class
• Use of WHO safe surgery checklist [ Time Frame: Intra-interventional ]
  Number of patients , where the WHO safe surgery checklist was used
• 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.
• Amount of pre-interventional comorbidities [ Time Frame: pre-interventional at baseline visit ]
  Number of comorbidities
• Albumin and hematocrit level before intervention [ Time Frame: pre-interventional at baseline visit ]
  Optional assessment, only if done in the clinical routine
• Number of falls in the last 6 months [ Time Frame: pre-interventional at baseline visit ]
  Number of falls per patient
• 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
• Pre-interventional timed "Up & Go" test [ Time Frame: pre-interventional at baseline visit ]
  Seconds to perform the up and go test will be measured
• Comparison of the patients' outcomes across Europe [ Time Frame: 30 days after intervention ]
  Comparing the number of adverse outcomes between the hospitals and countries

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 11, 2017)

• Age and gender-effect on the 30 day mortality [ Time Frame: 30 days after intervention ]
  Association of patient age/ gender and mortality
• Effect of pre-interventional morbidities on the 30 day mortality [ Time Frame: 30 days after intervention ]
  Association of pre-operative morbidities and mortality
• 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
• Effect of centre and country on the 30 day mortality [ Time Frame: 30 days after intervention ]
  Association of center/ country and mortality
• In-hospital cardiopulmonary resuscitation [ Time Frame: From intervention until hospital discharge or maximum 30-days after intervention ]
  Rate

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Periinterventional Outcome Study in the Elderly
• Official Title: Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients will be selected from secondary and tertiary hospitals in several countries in Europe.

Condition

• Mortality
• Complication, Postoperative

Intervention

Procedure: Surgical or non-surgical intervention

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

Study Groups/Cohorts

Elderly patient

Elderly patient undergoing surgical and non-surgical intervention with the use of anesthesia provided by an anesthetist

Intervention: Procedure: Surgical or non-surgical intervention

Publications *

• Kowark A, Berger M, Rossaint R, Schmid M, Coburn M; POSE-Study group. Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol. 2022 Mar 1;39(3):210-218. doi: 10.1097/EJA.0000000000001638.
• POSE-Study group. Peri-interventional outcome study in the elderly in Europe: A 30-day prospective cohort study. Eur J Anaesthesiol. 2022 Mar 1;39(3):198-209. doi: 10.1097/EJA.0000000000001639.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2019): 9500
• Original Estimated Enrollment (submitted: May 11, 2017): 7500
• Actual Study Completion Date: January 30, 2019
• Actual Primary Completion Date: January 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 80 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Denmark, France, Georgia, Germany, Greece, Ireland, Israel, Netherlands, North Macedonia, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Switzerland, Turkey, Ukraine
• Removed Location Countries: Cyprus, Italy, Macedonia, The Former Yugoslav Republic of, United Kingdom

Administrative Information

• NCT Number: NCT03152734
• Other Study ID Numbers: 17-070
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mark Coburn, RWTH Aachen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mark Coburn
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Mark Coburn, MD; Department of Anesthesiology, University Hospital Aachen, Germany

• PRS Account: RWTH Aachen University
• Verification Date: November 2019