Effect of Patient Position on Airway Heat ContentNCT02153164
Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
An observational study of Effect of Patient Position on Airway Heat Content, run by University of California, Davis.
Trial summary
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Effect of Patient Position on Airway Heat Content
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2016
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective surgery requiring steep Trendelenberg position.
Who may be able to join
- age greater than 18 years
- scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position
Who cannot join
- Adults unable to give primary consent
- age less than 18 years
- pregnancy
- prisoners
- infusion of inotropic drugs
- positive end expiratory pressure (PEEP) requirements >8 cm H2O Women, minorities or non-English speaking subjects will not be excluded.
About this study
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.
- Keywords
- Enthalpy, Trendelenberg position, Mechanical ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
Respired gas heat content
(6 months for protocol and 2 hours per patient)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Patient Position on Airway Heat ContentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 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, University of California Davis, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153164
- Sponsor's protocol ID
- 589602
- Status last verified
- Aug 2017
- First submitted
- 29 May 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Steep Trendelenburg Position on Respiratory Gas Heat Content
- ClinicalTrials.gov ID
- NCT02153164
- Acronym / sponsor ID
- 589602
- Keywords
- Enthalpy, Trendelenberg position, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jun 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 single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in patient position on the measurement of respiratory heat loss (enthalpy). This study would be carried out on patients whose operation requires the use of the steep Trendelenburg position independent of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective surgery requiring steep Trendelenberg position.
Key inclusion criteria (2 listed)
- age greater than 18 years
- scheduled for an elective surgical procedure requiring general anesthesia, positive pressure ventilation using an endotracheal tube and the steep Trendelenburg position
Key exclusion criteria (6 listed)
- Adults unable to give primary consent
- age less than 18 years
- pregnancy
- prisoners
- infusion of inotropic drugs
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
Respired gas heat content
Time frame: 6 months
(6 months for protocol and 2 hours per patient)
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 14 Aug 2017.
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
University of California Davis, Department of Anesthesiology and Pain Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Patient Position on Airway Heat Content, run by University of California, Davis.
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 6 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Respired gas heat content (time frame: 6 months). 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 14 Aug 2017.