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

NCT ID: NCT04188093

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-06-01

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.

Conditions

Complication,Postoperative; Post-Op Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

PACU discharge criteria and continuous monitoring on the ward

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Eske Kvanner Aasvang

Head of research, Clinical professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eske K Aasvang, Dr. Med.

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

PIRCPAC

Identifier Type: -

Identifier Source: org_study_id