InfectionNCT02077816
Using a Infrared Thermometer to the Early Detection of Catheter Related Infections
An observational study of Infection, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatient of the metabolic, clinical or intensive care wards with a CVC for medical care.
Who may be able to join
- Need of a central venous catheter for medical care.
- Be an inpatient of the metabolic, clinical or intensive care wards
Who cannot join
- Be in treatment course of a catheter related infection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Ribeirao Preto
Ribeirão Preto, São Paulo, 14091210
About this study
Official title: Using Non-contact Infrared Thermometry to Detection of Central Venous Catheter Related Infection.
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.
Read the detailed 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
- Conditions
- Infection
- Keywords
- body temperature, Thermometry, Infrared Rays, catheter related infection
- Medical subject headings
- Infections, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Central venous catheter | Inpatients with CVC for medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after bath, mobilization or warm or cold compresses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julio Sergio Marchini, University of Sao Paulo
- Investigators
- Júlio S Marchini, Ph.D, Principal investigator, Ribeirão Preto Medical School. São Paulo University (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077816
- Sponsor's protocol ID
- HCRP 12632/2010
- Other IDs
- CAAE - 0444.0.004.000-10
- Status last verified
- Mar 2014
- First submitted
- 2 Mar 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16267731Walshe 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.
PubMed 12149302Pittiruti 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.
PubMed 19464090Maiefski 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.
PubMed 19803767Safdar 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.
PubMed 12483050Raad 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.
PubMed 17897607Cheung 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.
PubMed 19439704Pires DPL, Afonso JC, Chaves FAB. A termometria nos séculos XIX e XX. Rev. Bras. Ensino Fís. 28(1): 101-114, 2006
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Non-contact Infrared Thermometry to Detection of Central Venous Catheter Related Infection.
- ClinicalTrials.gov ID
- NCT02077816
- Acronym / sponsor ID
- HCRP 12632/2010
- Conditions
- Infection
- Keywords
- body temperature, Thermometry, Infrared Rays, catheter related infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central venous catheter | – | –Inpatients with CVC for medical care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatient of the metabolic, clinical or intensive care wards with a CVC for medical care.
Key inclusion criteria (2 listed)
- Need of a central venous catheter for medical care.
- Be an inpatient of the metabolic, clinical or intensive care wards
Key exclusion criteria (1 listed)
- Be in treatment course of a catheter related infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body temperature measured with a non-contact infrared thermometer.
Time frame: 15 minutes after bath, mobilization or warm or cold compresses
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Background: PubMed 16267731Blot 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.
- Background: PubMed 12149302Walshe 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.
- Background: PubMed 19464090Pittiruti 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.
- Background: PubMed 19803767Maiefski 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.
- Background: PubMed 12483050Safdar 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.
- Background: PubMed 17897607Raad 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.
- Background: PubMed 19439704Cheung 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.
- BackgroundPires DPL, Afonso JC, Chaves FAB. A termometria nos séculos XIX e XX. Rev. Bras. Ensino Fís. 28(1): 101-114, 2006
- Record in the Brazilian Committee of Ethics in ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Júlio S Marchini, Ph.D principal investigator
Ribeirão Preto Medical School. São Paulo University (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature measured with a non-contact infrared thermometer. (time frame: 15 minutes after bath, mobilization or warm or cold compresses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02077816, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.