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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02077816
Other study ID # HCRP 12632/2010
Secondary ID CAAE - 0444.0.00
Status Completed
Phase N/A
First received March 2, 2014
Last updated March 2, 2014
Start date August 2011
Est. completion date November 2011

Study information

Verified date March 2014
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial 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.


Description:

By convenience sampling, it was expected that during 4 months, a minimum of 30 inpatients of the metabolic, clinical or intensive care wards, at the Clinical Hospital of Ribeirão Preto Medical School, São Paulo, Brazil, would have their data collected


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Need of a central venous catheter for medical care.

- Be an inpatient of the metabolic, clinical or intensive care wards

Exclusion Criteria:

- Be in treatment course of a catheter related infection.

Study Design

Time Perspective: Prospective


Locations

Country Name City State
Brazil Clinical Hospital of Ribeirao Preto Ribeirão Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. Epub 2005 Oct 25. — View Citation

Cheung E, Baerlocher MO, Asch M, Myers A. Venous access: a practical review for 2009. Can Fam Physician. 2009 May;55(5):494-6. Review. — View Citation

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. Review. Erratum in: Infect Control Hosp Epidemiol. 2010 Feb;31(2):202. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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