Respiratory Heat LossNCT01808963
Evaluation of Respiratory Heast Loss as a Physiologic Patient Monitor for Acute Care Medicine
An observational study of Respiratory Heat Loss, run by University of California, Davis at 1 site in United States.
Trial summary
To evaluate the utility of respiratory heat loss measurements as a physiologic monitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Heat Loss
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient undergoing elective surgery requiring arterial pressure monitoring.
Who may be able to join
- Elective surgical procedures.
Who cannot join
- Severe pulmonary disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.
Read the detailed description
Respiratory Heat Loss Measured in Joules Per Minute
- Conditions
- Respiratory Heat Loss
- Keywords
- Enthalpy, Physiologic Monitors, Critical Care Medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
Respired gas heat content
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Heat LossStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal W Fleming, M.D., Ph.D, Principal investigator, Director, Cardiovascular and Thoracic Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808963
- Sponsor's protocol ID
- 389048
- Status last verified
- May 2017
- First submitted
- 7 Mar 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
- ClinicalTrials.gov ID
- NCT01808963
- Acronym / sponsor ID
- 389048
- Conditions
- Respiratory Heat Loss
- Keywords
- Enthalpy, Physiologic Monitors, Critical Care Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Posted 8 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the utility of respiratory heat loss measurements as a physiologic monitor.
Detailed description
Respiratory Heat Loss Measured in Joules Per Minute
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient undergoing elective surgery requiring arterial pressure monitoring.
Key inclusion criteria (1 listed)
- Elective surgical procedures.
Key exclusion criteria (1 listed)
- Severe pulmonary disease.
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
Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine
Time frame: 1 year.
Respired gas heat content
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Neal W Fleming, M.D., Ph.D principal investigator
Director, Cardiovascular and Thoracic Anesthesiology
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 Respiratory Heat Loss, run by University of California, Davis at 1 site in United States.
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 1 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 30 May 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.