NCT04680208

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 7, 2020

Last Update Submit

December 19, 2020

Conditions

Outcome Measures

Primary Outcomes (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.

    1-2 days

Secondary Outcomes (2)

  • ICU length of stay

    1-30 days

  • Mortality

    1-45 days

Study Arms (2)

Planned ICU admission

Cases who were planned for postoperative ICU admission at the time of preanesthetic check up

Procedure: Surgical procedure under anesthesia

Unplanned ICU admission

Cases who got admitted to ICU postoperatively without anticipation

Procedure: Surgical procedure under anesthesia

Interventions

Different varieties of surgical procedures done under anesthesia

Planned ICU admissionUnplanned ICU admission

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Qaboos University Hospital,

Muscat, 123, Oman

Location

Related Publications (5)

  • 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.

    PMID: 28400682BACKGROUND
  • 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.

    PMID: 16749940BACKGROUND
  • 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.

    PMID: 10356016BACKGROUND
  • 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.

    PMID: 21457500BACKGROUND
  • 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.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jyoti Burad, M.D E.D.I.C

    Sultan Qaboos University Hospital

    PRINCIPAL INVESTIGATOR
  • Batool Al Ajmi, Student

    Sultan Qaboos University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Intensivist

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 22, 2020

Study Start

July 1, 2019

Primary Completion

October 31, 2019

Study Completion

June 30, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations