Indication, UnlabeledOPICUNCT05995925
Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)
An observational study of Indication, Unlabeled and Complication,Postoperative, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial will be carried out as a national multicenter observational cohort trial in Turkey. Our starting point is the need to triage postoperative patients daily due to the limited intensive care unit (ICU) bed capacity. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Indication, Unlabeled, Complication,Postoperative
- What is being tested?
- Clinical Observation
- How many people
- 1,300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 3 Apr 2024
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients requiring intensive care treatment in the postoperative period. The study population comprises individuals who have undergone surgery and require intensive care, regardless of whether their admission to the ICU was planned or unplanned.
Who may be able to join
- Age ≥ 18 years
- Major elective/emergency surgical procedures
- Planned, unplanned, emergent surgical procedures, planned but not admitted to the ICU after the operation.
- Patients who planned but not transferred to the ICU will also be followed/ included postoperatively
- Informed Consent
- Major surgeries will be targeted within the broad subgroup domains of gynecology, neurosurgery, thoracic, urology, orthopedics/trauma, and abdominal surgery.
- Unplanned but admitted to ICU after surgery in 48 hrs.
Who cannot join
- Day-case surgery
- Cardiac surgery
- Pediatric surgery
- Patients who were already staying in ICU and planned to be operated on
- Denial of informed consent
- All interventional procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University
Istanbul, 34450
Evren Senturk, Prof, MD, +90 212 338 10 00, esenturk@ku.edu.tr
About this study
This clinical trial will be carried out as a national multicenter observational cohort trial in Turkey. Our starting point is the need to triage postoperative patients daily due to the limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring emergency or unplanned ICU admission generally meet the ICU admission criteria. However, postoperative patients admitted to the ICU for planned reasons often do not meet the ICU admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit - PACU) for close observation purposes.
The primary aim is to assess the efficient utilization of ICU beds. We try to compare the treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU admission. Our secondary outcome is to identify criteria that can predict ICU indications based on patients' preoperative characteristics and evaluate the postoperative complications according to the Clavien-Dindo classification.
Our aim is to categorize patients admitted to the ICU into two groups: planned and unplanned/emergency cases and compare the necessity of ICU care between these two groups. The need for ICU treatment will be determined based on the criteria established in the following* study. The presence of any of these criteria will indicate the need for ICU admission, while the absence of these criteria may identify patients admitted to the ICU only for monitoring purposes (i.e., unnecessary ICU admissions).
Read the detailed description
Surgical cases involving patients over 18 years of age requiring postoperative intensive care will be included (including patients who were admitted urgently, or patients that is planned but not admitted to ICU after the surgery).
Cardiac surgery cases, outpatient cases, pediatric surgery cases, patients undergoing surgery while hospitalized in the ICU, patients undergoing only interventional procedures, and those who do not provide consent will be excluded from the study.
- Conditions
- Indication, Unlabeled, Complication,Postoperative
- Being tested
- Clinical Observation
- Keywords
- Intensive Care, Triage, Postoperative period
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ObservationOther
Clinical Observation
| Study group | Role | What they receive |
|---|---|---|
| Patients with planned ICU admission | Patients with preoperative planned ICU admission Receives: Other: Clinical Observation | |
| Patients with unplanned ICU admission | Patients with preoperative unplanned ICU admission Receives: Other: Clinical Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective use of ICU
To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units.
Measured: From 1 day before the surgery to the 30th day after the surgery.
Secondary outcomes (8)
Rates of postoperative complications
They will be assessed postoperatively using Clavien- Dindo classification
Measured: From the end of the surgery until discharge from the hospital
Length of ICU stay
The patient will be followed up from admission to the ICU until discharge from the ICU
Measured: From the end of the surgery until discharge from the ICU
Length of hospital stay.
The patient will be followed up from admission to the ICU until discharge from the hospital
Measured: From the end of the surgery until discharge from the hospital
ICU mortality
The patient will be followed up from admission to the ICU until discharge from the ICU
Measured: From the end of the surgery until discharge from the ICU
30-day hospital mortality
The patient will be followed up from admission to the ICU until his discharge from the hospital
Measured: From the end of the surgery until discharge from the hospital
Best scoring system for ICU admission
Identifying the best scoring system for ICU admission by comparing different scoring systems.
Measured: Preoperative from hospital admission until the patient's discharge from hospital following surgery.
Epidemiology of postoperative ICU admitted patients
Defining groups in postoperative patients according to their region or type of surgery
Measured: From preoperative hospital admission until discharge from the hospital
Risk factors or criteria for ICU admission after the surgery
During the entire perioperative process, the patient will be closely observed, vital signs, treatments and complications will be recorded.
Measured: From preoperative hospital admission until discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start3 Jan 2024
- Primary completion3 Feb 2024 (estimated)
- Study completion3 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Indication, UnlabeledStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evren Senturk, Koç University
- Investigators
- Nahit Cakar, Prof, MD, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995925
- Sponsor's protocol ID
- 2023.198.IRB1.065
- Acronym
- OPICU
- Status last verified
- Jan 2024
- First submitted
- 1 Aug 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
PubMed 22998715Jerath A, Laupacis A, Austin PC, Wunsch H, Wijeysundera DN. Intensive care utilization following major noncardiac surgical procedures in Ontario, Canada: a population-based study. Intensive Care Med. 2018 Sep;44(9):1427-1435. doi: 10.1007/s00134-018-5330-6. Epub 2018 Jul 27.
PubMed 30054691Zampieri FG, Lone NI, Bagshaw SM. Admission to intensive care unit after major surgery. Intensive Care Med. 2023 May;49(5):575-578. doi: 10.1007/s00134-023-07026-7. Epub 2023 Mar 22. No abstract available.
PubMed 36947198
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for Perioperative Care of Patients Requiring ICU (OPICU)
- ClinicalTrials.gov ID
- NCT05995925
- Acronym / sponsor ID
- OPICU / 2023.198.IRB1.065
- Conditions
- Indication, Unlabeled, Complication,Postoperative
- Keywords
- Intensive Care, Triage, Postoperative period
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 3 Feb 2024 (estimated)
- Study completion
- 3 Apr 2024 (estimated)
- First posted
- 16 Aug 2023 (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.
This clinical trial will be carried out as a national multicenter observational cohort trial in Turkey. Our starting point is the need to triage postoperative patients daily due to the limited intensive care unit (ICU) bed capacity. Our hypothesis is that patients requiring emergency or unplanned ICU admission generally meet the ICU admission criteria. However, postoperative patients admitted to the ICU for planned reasons often do not meet the ICU admission criteria and can be monitored in a lower-level unit (Postoperative Care Unit - PACU) for close observation purposes.
The primary aim is to assess the efficient utilization of ICU beds. We try to compare the treatments provided during ICU follow-up, for planned and unplanned patients requiring ICU admission. Our secondary outcome is to identify criteria that can predict ICU indications based on patients' preoperative characteristics and evaluate the postoperative complications according to the Clavien-Dindo classification.
Our aim is to categorize patients admitted to the ICU into two groups: planned and unplanned/emergency cases and compare the necessity of ICU care between these two groups. The need for ICU treatment will be determined based on the criteria established in the following* study. The presence of any of these criteria will indicate the need for ICU admission, while the absence of these criteria may identify patients admitted to the ICU only for monitoring purposes (i.e., unnecessary ICU admissions).
Detailed description
Surgical cases involving patients over 18 years of age requiring postoperative intensive care will be included (including patients who were admitted urgently, or patients that is planned but not admitted to ICU after the surgery).
Cardiac surgery cases, outpatient cases, pediatric surgery cases, patients undergoing surgery while hospitalized in the ICU, patients undergoing only interventional procedures, and those who do not provide consent will be excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with planned ICU admission | – | Other: Clinical ObservationPatients with preoperative planned ICU admission |
| Patients with unplanned ICU admission | – | Other: Clinical ObservationPatients with preoperative unplanned ICU admission |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients requiring intensive care treatment in the postoperative period. The study population comprises individuals who have undergone surgery and require intensive care, regardless of whether their admission to the ICU was planned or unplanned.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Major elective/emergency surgical procedures
- Planned, unplanned, emergent surgical procedures, planned but not admitted to the ICU after the operation.
- Patients who planned but not transferred to the ICU will also be followed/ included postoperatively
- Informed Consent
Key exclusion criteria (6 listed)
- Day-case surgery
- Cardiac surgery
- Pediatric surgery
- Patients who were already staying in ICU and planned to be operated on
- Denial of informed consent
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 |
|---|---|---|
| Clinical ObservationClinical Observation | Other | Patients with planned ICU admission, Patients with unplanned ICU admission |
Primary outcome
Effective use of ICU
Time frame: From 1 day before the surgery to the 30th day after the surgery.
To take a picture of the use of ICU beds in postoperative patients in Turkish intensive care units.
8 secondary outcomes
Rates of postoperative complications
Time frame: From the end of the surgery until discharge from the hospital
Length of ICU stay
Time frame: From the end of the surgery until discharge from the ICU
Length of hospital stay.
Time frame: From the end of the surgery until discharge from the hospital
ICU mortality
Time frame: From the end of the surgery until discharge from the ICU
30-day hospital mortality
Time frame: From the end of the surgery until discharge from the hospital
Best scoring system for ICU admission
Time frame: Preoperative from hospital admission until the patient's discharge from hospital following surgery.
Epidemiology of postoperative ICU admitted patients
Time frame: From preoperative hospital admission until discharge from the hospital
Risk factors or criteria for ICU admission after the surgery
Time frame: From preoperative hospital admission until discharge from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Results publication: PubMed 22998715Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
- Results publication: PubMed 30054691Jerath A, Laupacis A, Austin PC, Wunsch H, Wijeysundera DN. Intensive care utilization following major noncardiac surgical procedures in Ontario, Canada: a population-based study. Intensive Care Med. 2018 Sep;44(9):1427-1435. doi: 10.1007/s00134-018-5330-6. Epub 2018 Jul 27.
- Results publication: PubMed 36947198Zampieri FG, Lone NI, Bagshaw SM. Admission to intensive care unit after major surgery. Intensive Care Med. 2023 May;49(5):575-578. doi: 10.1007/s00134-023-07026-7. Epub 2023 Mar 22. No abstract available.
- 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.
Nahit Cakar, Prof, MD study chair
Koç University
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 Indication, Unlabeled and Complication,Postoperative, run by Koç University at 1 site in Turkey (Türkiye).
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evren Senturk, Prof, MD (+90 212 338 10 00, esenturk@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective use of ICU (time frame: From 1 day before the surgery to the 30th day after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995925, which also lists 3 linked publications.
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 31 Jan 2024.