- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04010474
Surgical APGAR Score and Modified Surgical APGAR Score
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Namigar Turgut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients who underwent elective major surgery (Abdominal and Orthopedic surgery) were included (n=308)
After the operation modified SAS (mSAS) was calculated by adding the duration of the operation to data used in calculation of the SAS (Table 1.).
Observed complications and related conditions were also noted.
Table 1. Modified Surgical Apgar Score (mSAS)
mSAS 0 1 2 3 4
Estimated blood loss, ml >1000 601-1000 101-600 ≤100 -
Lowest MAP*, mmHg <40 40-54 55-69 ≥70 -
Lowest HR**, beats per min >85 76-85 66-75 56-65 ≤55
Time -4 -3 -2 -1 0
Duration of operation (hour) >8 7.01-8 5.01-7 3.01-5 0-3
* MAP=Mean arterial pressure
Description
Inclusion Criteria:
- Subject has major surgery
- More than 18 years
Exclusion Criteria:
- Pregnant
- Younger than 18
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Time Frame: 01.06.2017 - 30.09.2017
|
Operation time should be included as a simple, objective and practical indication of the SAS risk score in the major operations in our study including a single-center, prospective 308 case study, as it can be seen as an independent predictor of postoperative mortality and complications.
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01.06.2017 - 30.09.2017
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Namigar Turgut, Prof.Dr, University of Health Seciences, Okmeydani Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.05.2017 658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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