Anesthesia Intubation ComplicationNCT03032939
The Effect of Tracheal Intubation on AC and DC Components of a Photoplethysmograph
An observational study of Anesthesia Intubation Complication, run by University of California, San Francisco.
Trial summary
Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2007to 30 Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elective, healthy surgical patients over 18 yrs of age
Who may be able to join
- Elective surgery
- General endotracheal anesthesia
- Over 18 years of age
- Healthy
Who cannot join
- Vascular disease
- Liver or kidney disease
- Overweight
About this study
Official title: The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography
Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal intubationProcedure or surgery
standard endotracheal intubation of surgical patients after induction of anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoplethysmography
changes in AC and DC components of photoplethysmography
Measured: within 60 seconds of intubation
Secondary outcomes (1)
Pulse rate
Pulse rate from photoplethysmograph
Measured: within 60 seconds of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start18 Dec 2007
- Primary completion30 Jan 2012
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pekka Talke, University of California, San Francisco
- Investigators
- Pekka O Talke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032939
- Sponsor's protocol ID
- PT071
- Status last verified
- Jan 2017
- First submitted
- 24 Jan 2017
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only a unique study number such as, IP01, that is unrelated to any patient identifiers will be used
Publications
Talke P. The Effect of Tracheal Intubation-Induced Autonomic Response on Photoplethysmography. Anesthesiol Res Pract. 2017;2017:7646541. doi: 10.1155/2017/7646541. Epub 2017 Apr 2.
PubMed 28469670
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tracheal Intubation Induced Autonomic Response on Photoplethysmography
- ClinicalTrials.gov ID
- NCT03032939
- Acronym / sponsor ID
- PT071
- Conditions
- Anesthesia Intubation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Dec 2007 (actual)
- Primary completion
- 30 Jan 2012 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 26 Jan 2017 (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.
Intraoperative stress responses (vasoconstriction and changes in heart rate) and postoperative pain can be monitored using photoplethysmography (PPG). PPG measures changes in tissue volume noninvasively. Therefore it can measure acute changes in arterial diameter (vasoconstriction). PPG signal has two components, AC and DC. Effects of noxious stimuli-induced stress responses (vasoconstriction) have not been studied on the DC component of PPG. The aim of this study was to investigate the effect of a known noxious stimulus (endotracheal intubation) on both the AC and DC components of PPG.
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
- Elective, healthy surgical patients over 18 yrs of age
Key inclusion criteria (4 listed)
- Elective surgery
- General endotracheal anesthesia
- Over 18 years of age
- Healthy
Key exclusion criteria (3 listed)
- Vascular disease
- Liver or kidney disease
- Overweight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal intubationstandard endotracheal intubation of surgical patients after induction of anesthesia | Procedure or surgery | – |
Primary outcome
Photoplethysmography
Time frame: within 60 seconds of intubation
changes in AC and DC components of photoplethysmography
1 secondary outcome
Pulse rate
Time frame: within 60 seconds of intubation
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 26 Jan 2017.
- Derived from this study: PubMed 28469670Talke P. The Effect of Tracheal Intubation-Induced Autonomic Response on Photoplethysmography. Anesthesiol Res Pract. 2017;2017:7646541. doi: 10.1155/2017/7646541. Epub 2017 Apr 2.
- Individual participant dataSharing planned: No. only a unique study number such as, IP01, that is unrelated to any patient identifiers will be used
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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.
Pekka O Talke, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Intubation Complication, run by University of California, San Francisco.
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 4 inclusion and 3 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 26 Jan 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?
Photoplethysmography (time frame: within 60 seconds of intubation). 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 NCT03032939, which also lists 1 linked publication.
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 26 Jan 2017.