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.
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
- Conditions the study is for
- Postoperative Complications, Comorbidities and Coexisting Conditions
- 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.
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 group | Role | What they receive |
|---|---|---|
| Planned ICU admission | Cases who were planned for postoperative ICU admission at the time of preanesthetic check up Receives: Procedure: Surgical procedure under anesthesia | |
| Unplanned ICU admission | Cases 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.
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)
ICU length of stay
Measured: 1-30 days
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.
- First posted22 Dec 2020
- Study start1 Jul 2019
- Primary completion31 Oct 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jyoti Barud, Sultan Qaboos University
- Investigators
- Jyoti Burad, M.D E.D.I.C, Principal investigator, Sultan Qaboos University HospitalBatool Al Ajmi, Student, Principal investigator, Sultan Qaboos University Hospital
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 28400682Pearse 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 16749940Smith 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 10356016Sobol 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 21457500Patel 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons and Outcomes of Direct Admission of Surgical Patients to ICU: A Three Years Retrospective Study at University Hospital
- ClinicalTrials.gov ID
- NCT04680208
- Acronym / sponsor ID
- MREC#1937
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 Dec 2020 (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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned ICU admission | – | Procedure: Surgical procedure under anesthesiaCases who were planned for postoperative ICU admission at the time of preanesthetic check up |
| Unplanned ICU admission | – | Procedure: Surgical procedure under anesthesiaCases who got admitted to ICU postoperatively without anticipation |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (above 18 years old) who underwent surgery and got admitted to ICU directly from operating theatre
Key inclusion criteria (1 listed)
- Adult patients over the age of 18 who underwent surgery and got admitted directly to ICU postoperatively
Key exclusion criteria (2 listed)
- Patients who were admitted to specialized ICU ( cardiothoracic and neurosurgery ) or to the ward and then ICU
- Pediatric patients
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 |
|---|---|---|
| Surgical procedure under anesthesiaDifferent varieties of surgical procedures done under anesthesia | Procedure or surgery | Planned ICU admission, Unplanned ICU admission |
Primary outcome
Reasons of admission for postoperative ICU patients.
Time frame: 1-2 days
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.
2 secondary outcomes
ICU length of stay
Time frame: 1-30 days
Mortality
Time frame: 1-45 days
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 22 Dec 2020.
- Background: PubMed 28400682Meziane 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.
- Background: PubMed 16749940Pearse 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.
- Background: PubMed 10356016Smith 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.
- Background: PubMed 21457500Sobol 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.
- Results publication: PubMed 29422726Patel 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.
- 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.
Jyoti Burad, M.D E.D.I.C principal investigator
Sultan Qaboos University Hospital
Batool Al Ajmi, Student principal investigator
Sultan Qaboos University Hospital
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 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.