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Surgical APGAR Score and Modified Surgical APGAR Score

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ClinicalTrials.gov Identifier: NCT04010474
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Tracking Information
First Submitted Date July 3, 2019
First Posted Date July 8, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date June 1, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surgical APGAR Score and Modified Surgical APGAR Score
Official Title Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Brief Summary In this study we aimed to define a new modified SAS is to predict the incidence of postoperative complication and mortality in major abdominal and orthopedic surgery. We also identify the effectivity of this modified scoring system composed of the duration of operation in addition to the three intraoperative parameters of SAS.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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

Condition Perioperative/Postoperative Complications
Intervention Procedure: Modified Surgical APGAR Score

Four intraoperative factors

  1. Lowest heart rate (HR),
  2. Lowest mean arterial pressure (MAP)
  3. Estimated blood loss
  4. Operation time
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 3, 2019)
308
Original Actual Enrollment Same as current
Actual Study Completion Date October 30, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject has major surgery
  • More than 18 years

Exclusion Criteria:

  • Pregnant
  • Younger than 18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010474
Other Study ID Numbers 09.05.2017 658
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study Sponsor Namigar Turgut
Collaborators Not Provided
Investigators
Study Director: Namigar Turgut, Prof.Dr University of Health Seciences, Okmeydani Training and Research Hospital
PRS Account Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Verification Date July 2019