Patient ComfortNCT04490369
Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
An observational study of Patient Comfort, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation. Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Comfort
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 30 Apr 2021
- 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: Adult patients coming to Duke University for Cardiac Catheterization
Who may be able to join
- English speaking
- Coming to Duke University for Cardiac Catheterization
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.
Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.
- Conditions
- Patient Comfort
- Keywords
- Procedural sedation, Cardiac Catheterization
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 |
|---|---|---|
| Group 1- short interval | Less than or equal to six minutes between receiving sedation and the start of the procedure | |
| Group 2- long interval | Greater than or equal to seven minutes between receiving sedation and the start of the procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total medication administration dosage as measured by the procedural database
Measured: During procedure, up to 2.5 hours
Frequency of medication administration as measured by the procedural database
Measured: During procedure, up to 2.5 hours
Secondary outcomes (2)
Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)
Measured: Within 2 hours of procedure
Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)
Measured: During procedure, to 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start7 Dec 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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 Patient ComfortStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradi Granger, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490369
- Sponsor's protocol ID
- Pro00102686
- Status last verified
- Jan 2022
- First submitted
- 24 Jul 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.
PubMed 36640418
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab
- ClinicalTrials.gov ID
- NCT04490369
- Acronym / sponsor ID
- Pro00102686
- Conditions
- Patient Comfort
- Keywords
- Procedural sedation, Cardiac Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Jul 2020 (actual)
- 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.
The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation.
Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- short interval | – | –Less than or equal to six minutes between receiving sedation and the start of the procedure |
| Group 2- long interval | – | –Greater than or equal to seven minutes between receiving sedation and the start of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients coming to Duke University for Cardiac Catheterization
Key inclusion criteria (2 listed)
- English speaking
- Coming to Duke University for Cardiac Catheterization
Key exclusion criteria (1 listed)
- -
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
Total medication administration dosage as measured by the procedural database
Time frame: During procedure, up to 2.5 hours
Frequency of medication administration as measured by the procedural database
Time frame: During procedure, up to 2.5 hours
2 secondary outcomes
Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS)
Time frame: Within 2 hours of procedure
Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT)
Time frame: During procedure, to 2.5 hours
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 3 Feb 2023.
- Results publication: PubMed 36640418Mall A, Girton TA, Yardley K, Ronn M, Cross E, Smith PJ, Rossman P, McEwen T, Ohman EM, Jones WS, Granger BB. Timing of sedation and patient-reported pain outcomes during cardiac catheterization: Results from the UNTAP-intervention study. Catheter Cardiovasc Interv. 2023 Jan 14. doi: 10.1002/ccd.30535. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Patient Comfort
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Recruiting
Breathing Meditation and VR Nature Videos in Angiography Patients: Effects on Anxiety, Comfort, and Physiology
Coronary Angiography, Virtual Reality
Enrolling by invitationObservational study
Real-World Validation of A Minimally Disruptive Ambulatory Blood Pressure Monitoring (ABPM) Huawei Smartwatch in Malaysia
Hypertension, Vascular Disease
Recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
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.
Bradi Granger, PhD principal investigator
Duke University
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 Patient Comfort, run by Duke University 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 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 3 Feb 2023. 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?
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?
Total medication administration dosage as measured by the procedural database (time frame: During procedure, up to 2.5 hours). The study lists 2 primary outcomes in all. 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 NCT04490369, 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 3 Feb 2023.