Complication,PostoperativeNCT04188093
Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria
An observational study of Complication,Postoperative and Post-Op Complication, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Complication,Postoperative, Post-Op Complication
- What is being tested?
- PACU discharge criteria and continuous monitoring on the ward
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Elective surgery
- Pancreaticoduodenectomy (KJLC30)
- Transthoracic esophageal resection without interposition (KJCC10)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting
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.
Read the 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
- Being tested
- PACU discharge criteria and continuous monitoring on the ward
- Keywords
- PACU, Postoperative Care Unit, Continous monitoring, PACU discharge criteria
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACU discharge criteria and continuous monitoring on the wardOther
- PACU discharge criteria (modified aldrete score).
- Continous monitoring of vital signs 96 postoperative hours
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: until discharge, up to 90 days
Secondary outcomes (10)
Bradycardia
pulse <40/min measured by pulse oximeter
Measured: During the first 4 postoperative days
Tachycardia
pulse >140/min meausured by pulseoximetry
Measured: During the first 4 postoperative days
Severe desaturation
Arterial saturation <85% lasting >10 minutes per episode, measured by pulse oximeter
Measured: During the first 4 postoperative days
Very severe desaturation
Arterial saturation <80% lasting >10 minutes per episode, measured by pulse oximeter
Measured: During the first 4 postoperative days
Hypotension
Middle arterial blood pressure <75 for >29 minutes measured by non-invasive manometer
Measured: During the first 4 postoperative days
Severe hypotension
Middle arterial blood pressure <65 for >29 minutes measured by non-invasive manometer
Measured: During the first 4 postoperative days
bradypnea
respiratory rate <8/min for 30 minutes, measured by ECG
Measured: During the first 4 postoperative days
Tachypnea
respiratory rate >20/min for 30 minutes, measured by ECG
Measured: During the first 4 postoperative days
Severe tachypnea
respiratory rate >30/min for 30 minutes, measured by ECG
Measured: During the first 4 postoperative days
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
Measured: until 96 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 2018
- Primary completion20 Jan 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, Dr. Med., Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188093
- Sponsor's protocol ID
- PIRCPAC
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria and Need for Interventions in the PACU Setting
- ClinicalTrials.gov ID
- NCT04188093
- Acronym / sponsor ID
- PIRCPAC
- Conditions
- Complication,Postoperative, Post-Op Complication
- Keywords
- PACU, Postoperative Care Unit, Continous monitoring, PACU discharge criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Elective surgery
- Pancreaticoduodenectomy (KJLC30)
- Transthoracic esophageal resection without interposition (KJCC10)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACU discharge criteria and continuous monitoring on the ward* PACU discharge criteria (modified aldrete score). * Continous monitoring of vital signs 96 postoperative hours | Other | – |
Primary outcome
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
10 secondary outcomes
Bradycardia
Time frame: During the first 4 postoperative days
Tachycardia
Time frame: During the first 4 postoperative days
Severe desaturation
Time frame: During the first 4 postoperative days
Very severe desaturation
Time frame: During the first 4 postoperative days
Hypotension
Time frame: During the first 4 postoperative days
Severe hypotension
Time frame: During the first 4 postoperative days
bradypnea
Time frame: During the first 4 postoperative days
Tachypnea
Time frame: During the first 4 postoperative days
Severe tachypnea
Time frame: During the first 4 postoperative days
Clinical out of hospital complications
Time frame: until 96 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske K Aasvang, Dr. Med. study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication,Postoperative and Post-Op Complication, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical in-hospital complications (time frame: until discharge, up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.