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

Post-Op Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188093
• Other study ID #: PIRCPAC
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: January 20, 2021
• Gender: All
• Age group: 60 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Post-Op Complication
• Postoperative Complications

Intervention

Other:
• PACU discharge criteria and continuous monitoring on the ward
PACU discharge criteria (modified aldrete score). Continous monitoring of vital signs 96 postoperative hours

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	description of other physiological deviations	description og frequency and duration of other physiological deviations (fever, arrythmia, apnea, arrythmia, etc)	during hospital stay, up to 30 days
Primary	Clinical in-hospital complications	Occurence of clinical complications occuring during the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions	until discharge, up to 90 days
Secondary	Bradycardia	pulse <40/min measured by pulse oximeter	During the first 4 postoperative days
Secondary	Tachycardia	pulse >140/min meausured by pulseoximetry	During the first 4 postoperative days
Secondary	Severe desaturation	Arterial saturation <85% lasting >10 minutes per episode, measured by pulse oximeter	During the first 4 postoperative days
Secondary	Very severe desaturation	Arterial saturation <80% lasting >10 minutes per episode, measured by pulse oximeter	During the first 4 postoperative days
Secondary	Hypotension	Middle arterial blood pressure <75 for >29 minutes measured by non-invasive manometer	During the first 4 postoperative days
Secondary	Severe hypotension	Middle arterial blood pressure <65 for >29 minutes measured by non-invasive manometer	During the first 4 postoperative days
Secondary	bradypnea	respiratory rate <8/min for 30 minutes, measured by ECG	During the first 4 postoperative days
Secondary	Tachypnea	respiratory rate >20/min for 30 minutes, measured by ECG	During the first 4 postoperative days
Secondary	Severe tachypnea	respiratory rate >30/min for 30 minutes, measured by ECG	During the first 4 postoperative days
Secondary	Clinical out of hospital complications	Occurence of clinical complications occuring after the hospital stay (pneumonia, myocardial infarction, brain stroke, renal impairment, etc), based upon international definitions	until 96 days postoperatively