Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Pneumonia Clinical Trial

Official title:

Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044428
• Other study ID #: Ek-Nr.: 35-251 ex 22/23
• Status: Recruiting
• Start date: August 14, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: Dr. Philipp Stiegler, Assoc. Prof.
• Phone: 004331638581181
• Email: philipp.stiegler[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to review whether postoperative infections can be detected earlier by a continuous measurement of body temperature of patients compared to single daily measurements. Within 25 weeks 100 patients, which underwent visceral surgery less than 48h ago, will be included. A patch (Steadytemp ®) will be attached to participants, continuously measuring the body temperature. In addition infection parameters and medication of the participants will be documented.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participant is willing and able to give informed consent for participation in the study

• age 18 years and above

• visceral surgery procedure within the last two days

• inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward

Exclusion Criteria:

• allergy to the ingredients of skin patches

• major psychiatric diseases including history of drug or alcohol abuse

• chronic inflammatory disease in the medical history

• predicted inpatient stay is less than 5 days

• operational wound is too close to the patch adhesive site

• the skin at the intended adhesive site of the patch is not intact

• BMI > 33

Related Conditions & MeSH terms

• Body Temperature
• Communicable Diseases
• Infections
• Pneumonia
• Postoperative Infection

Intervention

Device:
• Steadytemp®
Steadytemp® is a clinical thermometer intended to continuously measure axillary temperature and to display relative changes in axillary temperature to the user. The system consists of a sensor patch and a smartphone application, the body temperature measured by the sensor is transmitted via Near-Field-Communication (NFC) and subsequently displayed in the App.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperature curve (body temperature in °C)	temperature curve of the Steadytemp® Patch and single routine measurements (infrared)	min. 5 days and max. 21 days
Primary	wound infection or pneumonia	Number of patients diagnosed with wound infection or pneumonia	min. 5 days and max. 21 days
Secondary	Inflammation parameter in the blood: PCT (Procalcitonin)	PCT (Procalcitonin) level	min. 5 days and max. 21 days
Secondary	Inflammation parameter in the blood: CRP (c-reactive protein)	CRP (c-reactive protein) level	min. 5 days and max. 21 days
Secondary	Inflammation parameter in the blood: Leukocytes	Leukocytes count	min. 5 days and max. 21 days
Secondary	Use of medication	Use of medication like antibiotics, antiphlogistics, antipyretics	min. 5 days and max. 21 days