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Periinterventional Outcome Study in the Elderly (POSE)

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ClinicalTrials.gov Identifier: NCT03152734
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : November 20, 2019
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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