Patient SatisfactionFASTNCT04079543
NPO and Patient Satisfaction in the Cath Lab
A study testing NPO past midnight and NPO in people with Patient Satisfaction and Dehydration, run by Stony Brook University.
Trial summary
The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Dehydration, Physiological Effects Secondary to Dehydration
- What is being tested?
- NPO past midnight and NPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2019to 9 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older,
- patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
- ability to provide written informed consent
Who cannot join
- Age less than 18 years
- emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
- patients not alert and oriented to person, place, and date,
- concurrent surgical procedures on the day of TAVR or arrhythmia ablation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab
The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.
Read the detailed description
After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.
- Being tested
- NPO past midnight, NPO
- Keywords
- Nil per os (NPO), TAVR, arrhythmia ablation
- Medical subject headings
- Patient Satisfaction, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPO past midnightOther
NPO after midnight (solids and liquids), except for a sip of water with medication.
NPOOther
No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.
| Study group | Role | What they receive |
|---|---|---|
| Strict NPO | Other | NPO after midnight. No solids or liquids after midnight. Receives: Other: NPO past midnight |
| Liberal NPO | Other | No solids after midnight. Clear liquids up to 2 hours prior to surgery. Receives: Other: NPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction: survey
The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.
Measured: Up to 24 hours
Secondary outcomes (1)
Exploratory Analyses
An independent analysis of each individual component of the satisfaction survey will be performed. Each variable will be scored on a scale of 0-10. Variables: thirst, hunger, headache, nausea, lightheadedness, anxiety.
- Renal Function
- Vasopressor Requirement
- Post-operative nausea and vomiting
- Post-operative hospital length of stay
Measured: Through the end of hospitalization, usually 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start9 Sep 2019 (estimated)
- Primary completion9 Sep 2020 (estimated)
- Study completion9 Sep 2021 (estimated)
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 SatisfactionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized (1:1) into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Atkinson, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079543
- Sponsor's protocol ID
- IRB2019-00261
- Acronym
- FAST
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atkinson DJ, Romeiser JL, Almasry IO, Tannous HJ, Parikh PB, Bennett-Guerrero E. Randomized controlled trial of liberal vs. standard fasting instructions in percutaneous cardiac procedures. Perioper Med (Lond). 2023 Aug 8;12(1):44. doi: 10.1186/s13741-023-00333-z.
PubMed 37553699
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab
- ClinicalTrials.gov ID
- NCT04079543
- Acronym / sponsor ID
- FAST / IRB2019-00261
- Keywords
- Nil per os (NPO), TAVR, arrhythmia ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (estimated)
- Primary completion
- 9 Sep 2020 (estimated)
- Study completion
- 9 Sep 2021 (estimated)
- First posted
- 6 Sep 2019 (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 randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.
Detailed description
After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized (1:1) into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure).
| Arm | Type | Receives |
|---|---|---|
| Strict NPO | Other | Other: NPO past midnightNPO after midnight. No solids or liquids after midnight. |
| Liberal NPO | Other | Other: NPONo solids after midnight. Clear liquids up to 2 hours prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older,
- patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
- ability to provide written informed consent
Key exclusion criteria (4 listed)
- Age less than 18 years
- emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
- patients not alert and oriented to person, place, and date,
- concurrent surgical procedures on the day of TAVR or arrhythmia ablation.
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 |
|---|---|---|
| NPO past midnightNPO after midnight (solids and liquids), except for a sip of water with medication. | Other | Strict NPO |
| NPONo solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water. | Other | Liberal NPO |
Primary outcome
Patient Satisfaction: survey
Time frame: Up to 24 hours
The primary objective is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction. Patient satisfaction will be determined by a patient satisfaction survey given 2 hours (+/- 2 hrs) prior to procedure. This survey will assess: thirst, hunger, headache, nausea, lightheadedness, and anxiety.
1 secondary outcome
Exploratory Analyses
Time frame: Through the end of hospitalization, usually 2 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 37553699Atkinson DJ, Romeiser JL, Almasry IO, Tannous HJ, Parikh PB, Bennett-Guerrero E. Randomized controlled trial of liberal vs. standard fasting instructions in percutaneous cardiac procedures. Perioper Med (Lond). 2023 Aug 8;12(1):44. doi: 10.1186/s13741-023-00333-z.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing NPO past midnight and NPO in people with Patient Satisfaction and Dehydration, run by Stony Brook University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek Atkinson, MD (631-748-9310, derek.atkinson@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction: survey (time frame: Up to 24 hours). 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 NCT04079543, 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 6 Sep 2019.