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NCT Number: NCT04188093

Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria

In the Postoperative Care Unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. This study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (PACU) discharge criteria, a modified Aldretes score. Secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.

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Key information

Conditions

Complication,Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

Patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. Described patient groups are monitored for at least 24 hours in PACU before returning to the ward.

In Denmark physiological parameters are assessed in the PACU every hour until discharge using the DASAIM discharge criteria (A modified Aldrete score).

The PACU discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. Each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem.

The investigators will investigate the predictive value of the PACU discharge criteria and interventions in the PACU setting, to identify patients at risk of developing postoperative complications. Secondary outcome is micro events on the ward. Patients vital signs are monitored continuously from PACU discharge until the 5th postoperative day. Micro events are defined as deviations of vital parameters from normal range.

Who can participate

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

Inclusion criteria

  • Elective surgery
  • Pancreaticoduodenectomy (KJLC30)
  • Transthoracic esophageal resection without interposition (KJCC10)

Exclusion criteria

  • Patients not expected to be able to cooperate
  • Patients not cognitive well (Mini Mental State Examination < 24)
  • Pacemaker
  • Patients with allergies including band aid, plastic and silicone

Treatment and study plan

PACU discharge criteria and continuous monitoring on the ward

Other
  • PACU discharge criteria (modified aldrete score).
  • Continous monitoring of vital signs 96 postoperative hours

Primary outcomes

  1. Clinical in-hospital complications

    Time frame: until discharge, up to 90 days

    Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions

Secondary outcomes

  1. Bradycardia

    Time frame: During the first 4 postoperative days

    pulse <40/min measured by pulse oximeter

  2. Tachycardia

    Time frame: During the first 4 postoperative days

    pulse >140/min meausured by pulseoximetry

  3. Severe desaturation

    Time frame: During the first 4 postoperative days

    Arterial saturation <85% lasting >10 minutes per episode, measured by pulse oximeter

  4. Very severe desaturation

    Time frame: During the first 4 postoperative days

    Arterial saturation <80% lasting >10 minutes per episode, measured by pulse oximeter

  5. Hypotension

    Time frame: During the first 4 postoperative days

    Middle arterial blood pressure <75 for >29 minutes measured by non-invasive manometer

  6. Severe hypotension

    Time frame: During the first 4 postoperative days

    Middle arterial blood pressure <65 for >29 minutes measured by non-invasive manometer

  7. bradypnea

    Time frame: During the first 4 postoperative days

    respiratory rate <8/min for 30 minutes, measured by ECG

  8. Tachypnea

    Time frame: During the first 4 postoperative days

    respiratory rate >20/min for 30 minutes, measured by ECG

  9. Severe tachypnea

    Time frame: During the first 4 postoperative days

    respiratory rate >30/min for 30 minutes, measured by ECG

  10. Clinical out of hospital complications

    Time frame: until 96 days postoperatively

    Occurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions

Other outcomes

  1. description of other physiological deviations

    Time frame: during hospital stay, up to 30 days

    description og frequency and duration of other physiological deviations (fever, arrythmia, apnea, arrythmia, etc)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2019
Registry last updated
Jan 11, 2022

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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