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Postoperative ComplicationsNCT04680208

Study of Direct Admission of Postoperative Patients to ICU

An observational study of Postoperative Complications and Comorbidities and Coexisting Conditions, run by Sultan Qaboos University at 1 site in Oman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: This study assessed perioperative factors associated with planned and unplanned postoperative ICU admission and evaluated the outcome of the two groups. There are limited researches evaluating these factors. Read more about this study

Who is it for?
Ages 18 to 82 years
What is being tested?
Surgical procedure under anesthesia
Type of treatment
Surgery or procedure
How many people
68 participants
Where
1 siteOman
Study dates
1 Jul 2019to 30 Jun 2020
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 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (above 18 years old) who underwent surgery and got admitted to ICU directly from operating theatre

Who may be able to join

  • Adult patients over the age of 18 who underwent surgery and got admitted directly to ICU postoperatively

Who cannot join

  • Patients who were admitted to specialized ICU ( cardiothoracic and neurosurgery ) or to the ward and then ICU
  • Pediatric patients

Trial locations and contacts

1 site in 1 country.

Oman1 site
  • Sultan Qaboos University Hospital,

    Muscat, 123

Other trials in Oman

About this study

Official title: Reasons and Outcomes of Direct Admission of Surgical Patients to ICU: A Three Years Retrospective Study at University Hospital

Background: This study assessed perioperative factors associated with planned and unplanned postoperative ICU admission and evaluated the outcome of the two groups. There are limited researches evaluating these factors. Hence, it is important to do an audit that assesses the perioperative factors to help creating a criteria for postoperative ICU admissions.

Materials and methods: This retrospective study evaluated medical records of 68 patients above 18 years between January'2016- December'2018 that were admitted to ICU postoperatively in Sultan Qaboos University hospital in Oman. Both planned and unplanned admissions were assessed who underwent elective as well as emergency surgeries. Neurologic and cardiothoracic surgeries were excluded. Data collected included patient's demographics, social status like smoking, ASA physical status (American Society of Anesthesiologists), associated comorbidities, other perioperative factors and investigations, surgical and anesthesia details were recorded. The primary outcome studied was reasons of admission for planned versus unplanned postoperative ICU admissions. The secondary outcomes included mortality outcome and length of stay in ICU.

Read the detailed description

There are 2 Levels of care available for patients who require high level of organ support and monitoring. First of them is the high dependency unit (HDU) where higher level organ support and monitoring is given (exception for mechanical ventilation) such as invasive blood pressure monitoring. Second one is the intensive care unit (ICU), which provides support for patients with multiple organ dysfunction that needs higher level of care which cannot be provided in the ward or the high dependency unit (HDU) and without this care the patient may not survive.

ICU admission post-operatively can be either in a planned or unplanned way. The complex interaction between associated comorbidities, anticipated complications intra-operatively and high American Society of Anesthesiologists (ASA) Physical Status are major factors in planning for ICU admission post-operatively. ASA physical status indicates patient's health status and has been accepted as a determinant of comorbidity and mortality. Unplanned ICU admissions can be due to unpredicted surgical or anesthetic intra-operative complications or poor assessment of perioperative factors. After surgery, some patients are admitted to ICU for further management and monitoring based on their underlying low functional status and co-morbidities. Out of these some patients may actually need ICU interventions and others may not. If an ICU bed is booked for unworthy patient, this may lead to unnecessary increased expenditure, wastage of valuable resources as well as deny the ICU services to potentially survivable and worthy critically ill patient.

This study aimed to assess perioperative factors associated with planned and unplanned admissions to find out the main reasons of admission to ICU at Sultan Qaboos University hospital (SQUH). This will help to lay guideline for guiding future admission to ICU for surgical patients in immediate postoperative period and help to reduce the unplanned admission.

Methods

This retrospective observational study traced all adult patients (above 18 years old) who underwent surgery and got admitted to ICU directly from operating theatre during the 3-year period: 2016-2018 at SQUH. These were segregated into planned and unplanned admissions. Required information was accessed using the hospital information system after receiving the ethical approval from Sultan Qaboos University Hospital Ethics and Research Committee (MREC#1937). Patients who were admitted to specialized ICU and those who underwent neurologic or cardiothoracic operations were excluded from this study since they are admitted postoperatively to ICU by default.

Patient's data that were collected included age, gender, social status like smoking, ASA physical status (American Society of Anesthesiologists), associated comorbidities such as diabetes, hypertension, ischemic heart disease, valvular heart disease, pulmonary diseases, chronic kidney disease and cirrhosis. Associated factors and investigations were collected like dehydration, hypoxia, hypercarbia, pH changes, pulmonary complications, fluid/electrolyte imbalance, temperature changes, random blood sugar, sepsis, coagulopathy, elevated WBC, low hemoglobin, hemodynamic instability, septic shock, hypovolemic shock, infection, blood loss more than 20%, hypotension and cardiac arrhythmia. Type, nature and duration of surgery, type of anesthesia and airway issues were recorded. Patients mortality outcome and length of stay in ICU were included as well.

Statistical methods: Statistical Package for the Social Sciences (SPSS) was used for patient's data analysis. Descriptive statistics were used to determine median, frequencies and percentages of the data and were presented in form of graphs and tables. For testing the significance between the way of ICU admission (planned/unplanned) and different variables, Chi-square and Fisher's exact test were used. To assess risk factors of mortality outcome and long ICU stay, odds ratio was used. P-value of 0.05 or less was considered to be significant.

Being tested
Surgical procedure under anesthesia
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical procedure under anesthesiaProcedure or surgery

    Different varieties of surgical procedures done under anesthesia

Study groups in NCT04680208
Study groupRoleWhat they receive
Planned ICU admissionCases who were planned for postoperative ICU admission at the time of preanesthetic check up
Receives: Procedure: Surgical procedure under anesthesia
Unplanned ICU admissionCases who got admitted to ICU postoperatively without anticipation
Receives: Procedure: Surgical procedure under anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reasons of admission for postoperative ICU patients.

    Study of main reasons of ICU admissions directly from operating room. The reasons like type of surgery, ASA grading, preoperative functional status, co-morbidities: diabetes, hypertension, ischemic heart disease etc, intraoperative events like hemodynamic instability/shock, respiratory compromise, prolonged duration of surgery and other anesthesia complications will be studied as reasons of admission for planned versus unplanned ICU admissions for postoperative patients.

    Measured: 1-2 days

Secondary outcomes (2)
  1. ICU length of stay

    Measured: 1-30 days

  2. Mortality

    Postoperative mortality

    Measured: 1-45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start1 Jul 2019
  3. Primary completion31 Oct 2019
  4. Study completion30 Jun 2020

Resources

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
Case only
Time perspective
Retrospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680208
Sponsor's protocol ID
MREC#1937
Status last verified
Dec 2020
First submitted
7 Dec 2020
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Meziane M, El Jaouhari SD, ElKoundi A, Bensghir M, Baba H, Ahtil R, Aboulaala K, Balkhi H, Haimeur C. Unplanned Intensive Care Unit Admission following Elective Surgical Adverse Events: Incidence, Patient Characteristics, Preventability, and Outcome. Indian J Crit Care Med. 2017 Mar;21(3):127-130. doi: 10.4103/ijccm.IJCCM_428_16.

    PubMed 28400682
  • Pearse RM, Harrison DA, James P, Watson D, Hinds C, Rhodes A, Grounds RM, Bennett ED. Identification and characterisation of the high-risk surgical population in the United Kingdom. Crit Care. 2006;10(3):R81. doi: 10.1186/cc4928. Epub 2006 Jun 2.

    PubMed 16749940
  • Smith G, Nielsen M. ABC of intensive care. Criteria for admission. BMJ. 1999 Jun 5;318(7197):1544-7. doi: 10.1136/bmj.318.7197.1544. No abstract available.

    PubMed 10356016
  • Sobol JB, Wunsch H. Triage of high-risk surgical patients for intensive care. Crit Care. 2011;15(2):217. doi: 10.1186/cc9999. Epub 2011 Mar 22. No abstract available.

    PubMed 21457500
  • Patel SK, Kacheriwala SM, Duttaroy DD. Audit of Postoperative Surgical Intensive Care Unit Admissions. Indian J Crit Care Med. 2018 Jan;22(1):10-15. doi: 10.4103/ijccm.IJCCM_387_17.

    PubMed 29422726

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications and Comorbidities and Coexisting Conditions, run by Sultan Qaboos University at 1 site in Oman.

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 1 inclusion and 2 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 22 Dec 2020. 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 Oman. 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?

Reasons of admission for postoperative ICU patients. (time frame: 1-2 days). 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 NCT04680208, which also lists 5 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 22 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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