Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Knee Arthroplasty

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: NCT04575246
Recruitment Status : Completed
First Posted : October 5, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Anum Sadruddin, Aga Khan University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.

Condition or disease
Knee Arthroplasty, Total Hypothermia

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 286 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Total Knee Arthroplasty: A Retrospective Cross-sectional Study From a Developing Country
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Surgical Site Infection (SSI) [ Time Frame: 2016-2017 ]
    Post-operative infection caused total knee arthroplasty

  2. Post-operative hypothermia [ Time Frame: Within an hour after surgery ]
    Body temperature after surgery when patient is in the recovery room.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Sampling Method:   Non-Probability Sample
Study Population
All adults greater than 18 years undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University were included in this study. A standardized proforma was used to collect data from online patient data system about patients' preoperative, intraoperative and postoperative details. Preoperative data included age, gender, and comorbid conditions. Intraoperative data was collected from the surgical and anaesthesia records and included surgical site, American Society of Anesthesiologists (ASA) Level, duration of surgery, preoperative body temperature, intraoperative body temperature and duration of surgery. Postoperative data included post-operative body temperature and whether the patient developed any surgical site infection.
Criteria

Inclusion Criteria:

  • All adults greater than 18 years who underwent total knee arthroplasty.

Exclusion Criteria:

  • Any patient below 18 years
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Anum Sadruddin, Research Associate, Aga Khan University
ClinicalTrials.gov Identifier: NCT04575246    
Other Study ID Numbers: 2019-1274-3270
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypothermia
Body Temperature Changes