NCT05292937

Brief Summary

Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in pediatric patients in the operating room, and to detect the possible associated risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
Last Updated

December 31, 2024

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 14, 2022

Last Update Submit

December 29, 2024

Conditions

Hypothermia; AnesthesiaHypothermia Following Anesthesia

Keywords

hypothermiaintraoperativeperioperativepostoperative

Outcome Measures

Primary Outcomes (1)

  • Body temperature

    Body temperature of the patients will be measured via infrared thermometer.

    Perioperative

Interventions

Measurement of body temperatureDIAGNOSTIC_TEST

The patients' body temperature will be measured pre-, intra- and post-operatively via an infrared thermometer.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients scheduled for any elective operation (except for open heart surgery) will be recruited.

You may qualify if:

  • Any elective operation
  • American Society of Anaesthesiologists (ASA) I-III physical status
  • Age 0-18 years

You may not qualify if:

  • Emergency operations
  • ASA IV-V physical status
  • Open heart surgeries
  • Age \>=18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruslan Abdullayev

    Marmara University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

September 10, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

December 31, 2024

Record last verified: 2023-03

Locations

TU(1)