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Study of Direct Admission of Postoperative Patients to ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04680208
Recruitment Status : Completed
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Jyoti Barud, Sultan Qaboos University

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.


Condition or disease Intervention/treatment
Postoperative Complications Comorbidities and Coexisting Conditions Procedure: Surgical procedure under anesthesia

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Reasons and Outcomes of Direct Admission of Surgical Patients to ICU: A Three Years Retrospective Study at University Hospital
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Planned ICU admission
Cases who were planned for postoperative ICU admission at the time of preanesthetic check up
Procedure: Surgical procedure under anesthesia
Different varieties of surgical procedures done under anesthesia

Unplanned ICU admission
Cases who got admitted to ICU postoperatively without anticipation
Procedure: Surgical procedure under anesthesia
Different varieties of surgical procedures done under anesthesia




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: 1-30 days ]
  2. Mortality [ Time Frame: 1-45 days ]
    Postoperative mortality



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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients (above 18 years old) who underwent surgery and got admitted to ICU directly from operating theatre
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680208


Locations
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Oman
Sultan Qaboos University Hospital,
Muscat, Oman, 123
Sponsors and Collaborators
Sultan Qaboos University
Investigators
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Principal Investigator: Jyoti Burad, M.D E.D.I.C Sultan Qaboos University Hospital
Principal Investigator: Batool Al Ajmi, Student Sultan Qaboos University Hospital
Publications of Results:
Other Publications:
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Responsible Party: Dr Jyoti Barud, Consultant Intensivist, Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT04680208    
Other Study ID Numbers: MREC#1937
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs