Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical APGAR Score and Modified Surgical APGAR Score

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: 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

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.

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 308 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Surgical APGAR Score and Modified Surgical APGAR Score in Predicting Possible Postoperative Complications in Major Surgery
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery


Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Subject has major surgery
  • More than 18 years

Exclusion Criteria:

  • Pregnant
  • Younger than 18

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): NCT04010474


Locations
Layout table for location information
Turkey
Namigar Turgut
Istanbul, Turkey
Sponsors and Collaborators
Namigar Turgut
Investigators
Layout table for investigator information
Study Director: Namigar Turgut, Prof.Dr University of Health Seciences, Okmeydani Training and Research Hospital
Layout table for additonal information
Responsible Party: Namigar Turgut, Prof.Dr, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
ClinicalTrials.gov Identifier: NCT04010474    
Other Study ID Numbers: 09.05.2017 658
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Namigar Turgut, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization:
Complication
Mortality
Modified
Surgical Apgar Score
Additional relevant MeSH terms:
Layout table for MeSH terms
Postoperative Complications
Pathologic Processes