NCT02077816

Brief Summary

This is a pilot study which aims to show the temperatures measured on body surface with an infrared thermometer on inpatients who need a central venous catheter (CVC) for medical care. Because the local temperature could be altered, at least during local infectious processes, seems to be reasonable to think that this approach could be helpful to its early diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

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

August 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
Last Updated

March 4, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 2, 2014

Last Update Submit

March 2, 2014

Conditions

Infection

Keywords

body temperatureThermometryInfrared Rayscatheter related infection

Outcome Measures

Primary Outcomes (1)

  • Body temperature measured with a non-contact infrared thermometer.

    It was used a non-contact forehead infrared thermometer, model IR200® (Extech, USA). Fifteen minutes after bath, mobilization or warm or cold compresses, 3 measurements were obtained at the following sites: 1) close to CVC insertion, 2) at the equivalent contralateral site of CVC and 3) at the forehead. The variables values will be displayed in form of descriptive statistics (mean, standard deviation, standard error, proportions of the observations, confidence intervals) according to: sex, central venous catheter type (guide wire or port-a-cath), location of insertion, reason of the central venous catheter indication (like parenteral nutrition or antibiotics), number of catheter lumens and age. Also, the mean differences between the three locations measured will be presented.

    15 minutes after bath, mobilization or warm or cold compresses

Study Arms (1)

Central venous catheter

Inpatients with CVC for medical care.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient of the metabolic, clinical or intensive care wards with a CVC for medical care.

You may qualify if:

  • Need of a central venous catheter for medical care.
  • Be an inpatient of the metabolic, clinical or intensive care wards

You may not qualify if:

  • Be in treatment course of a catheter related infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14091210, Brazil

Location

Related Publications (8)

  • Blot SI, Depuydt P, Annemans L, Benoit D, Hoste E, De Waele JJ, Decruyenaere J, Vogelaers D, Colardyn F, Vandewoude KH. Clinical and economic outcomes in critically ill patients with nosocomial catheter-related bloodstream infections. Clin Infect Dis. 2005 Dec 1;41(11):1591-8. doi: 10.1086/497833. Epub 2005 Oct 25.

    PMID: 16267731BACKGROUND

  • Walshe LJ, Malak SF, Eagan J, Sepkowitz KA. Complication rates among cancer patients with peripherally inserted central catheters. J Clin Oncol. 2002 Aug 1;20(15):3276-81. doi: 10.1200/JCO.2002.11.135.

    PMID: 12149302BACKGROUND

  • Pittiruti M, Hamilton H, Biffi R, MacFie J, Pertkiewicz M; ESPEN. ESPEN Guidelines on Parenteral Nutrition: central venous catheters (access, care, diagnosis and therapy of complications). Clin Nutr. 2009 Aug;28(4):365-77. doi: 10.1016/j.clnu.2009.03.015. Epub 2009 May 21.

    PMID: 19464090BACKGROUND

  • Maiefski M, Rupp ME, Hermsen ED. Ethanol lock technique: review of the literature. Infect Control Hosp Epidemiol. 2009 Nov;30(11):1096-108. doi: 10.1086/606162.

    PMID: 19803767BACKGROUND

  • Safdar N, Maki DG. Inflammation at the insertion site is not predictive of catheter-related bloodstream infection with short-term, noncuffed central venous catheters. Crit Care Med. 2002 Dec;30(12):2632-5. doi: 10.1097/00003246-200212000-00003.

    PMID: 12483050BACKGROUND

  • Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.

    PMID: 17897607BACKGROUND

  • Cheung E, Baerlocher MO, Asch M, Myers A. Venous access: a practical review for 2009. Can Fam Physician. 2009 May;55(5):494-6. No abstract available.

    PMID: 19439704BACKGROUND

  • Pires DPL, Afonso JC, Chaves FAB. A termometria nos séculos XIX e XX. Rev. Bras. Ensino Fís. 28(1): 101-114, 2006

    BACKGROUND

Related Links

MeSH Terms

Conditions

InfectionsCatheter-Related Infections

Study Officials

  • Júlio S Marchini, Ph.D

    Ribeirão Preto Medical School. São Paulo University (USP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Internal Medicine Department at Ribeirão Preto Medical School

Study Record Dates

First Submitted

March 2, 2014

First Posted

March 4, 2014

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

March 4, 2014

Record last verified: 2014-03

Locations

BR(1)