Clinical trial NCT04188093: Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria
Official title: Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication,Postoperative
Post-Op Complication
Keywords: PACU
Postoperative Care Unit
Continous monitoring
PACU discharge criteria
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 60 years under surgery for abdominal cancer.

* Pancreaticoduodenectomy (KJLC30)
* transthoracic esophageal resection without interposition (KJCC10)

Patients undergoing described surgery stay at least 24 hours in PACU following local guidelines

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical in-hospital complications
timeFrame: until discharge, up to 90 days
Secondary outcomes:
measure: Bradycardia
timeFrame: During the first 4 postoperative days
measure: Tachycardia
timeFrame: During the first 4 postoperative days
measure: Severe desaturation
timeFrame: During the first 4 postoperative days
measure: Very severe desaturation
timeFrame: During the first 4 postoperative days
measure: Hypotension
timeFrame: During the first 4 postoperative days
measure: Severe hypotension
timeFrame: During the first 4 postoperative days
measure: bradypnea
timeFrame: During the first 4 postoperative days
measure: Tachypnea
timeFrame: During the first 4 postoperative days
measure: Severe tachypnea
timeFrame: During the first 4 postoperative days
measure: Clinical out of hospital complications
timeFrame: until 96 days postoperatively
Other outcomes:
measure: description of other physiological deviations
timeFrame: during hospital stay, up to 30 days
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, Dr. Med.
role: STUDY_CHAIR
References: