Fasting Clinical Trial
— FANPRECCOfficial title:
Fasting Versus Non-fasting Prior To Elective Cardiac Catheterization
NCT number | NCT03555500 |
Other study ID # | 215149 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2017 |
Est. completion date | March 10, 2019 |
The current practice of fasting before cardiac catheterization is not based on any studies.
If the procedure is to be delayed ( which is common due to busy catheterization lab), this
could result in patient's dis-satisfaction and hypoglycemia. Occasionally, cancellation occur
because patients are found to be non fasting ( not following the current protocol). The old
data of fasting was extrapolated from procedure done under general anesthesia. Now days,
cardiac catheterization is always done under local anesthesia and mild sedation. As a matter
of fact, emergency cardiac catheterization done for heart attack patients carries more risk
than elective one , and are still done without fasting with no reported complication rate
like lung aspiration . The highest level of evidence to change the current practice comes
from randomized control study. This study has been designed to challenge the current
practice. The patients will be divided into 2 groups:
- Fasting group (current practice): Clear fluids up to the time of the procedure and no
food for at least 2 hours before the procedure.
- Non Fasting Group: clear fluids and food and up to the time of the procedure
The investigators' aim is to show that there is no difference with regards to potential
complications between fasting (current practice) and non fasting (new practice) groups of
patients with less incidence of hypoglycemia and hypotension in non fasting group. In
addition, The investigators believe that patient satisfaction will be improved if patients
are allowed to eat freely before the procedure and the catheter lab working ability will be
maximized as the list can be filled promptly with patient on the waiting list (as fasting is
no longer required) if a previously booked patient has to be cancelled in the last minute
improving patient experience along with the associated financial benefits.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | March 10, 2019 |
Est. primary completion date | December 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients >18 years undergoing elective coronary angiography or angioplasty procedures Exclusion Criteria: - Patient choice - Other cardiac procedures such as EP studies, pacing, structural heart disease intervention - Emergency PPCI - Patients already admitted in the hospital with UA / NSTEMI - Patients unable to give informed consent (vulnerable group) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Blackpool Victoria Hospital | Blackpool | Lancashire |
Lead Sponsor | Collaborator |
---|---|
Blackpool Victoria Hospital |
United Kingdom,
Association of Anaesthetists of Great Britain and Ireland, Farling PA, Flynn PA, Darwent G, De Wilde J, Grainger D, King S, McBrien ME, Menon DK, Ridgway JP, Sury M, Thornton J, Wilson SR. Safety in magnetic resonance units: an update. Anaesthesia. 2010 Jul;65(7):766-70. doi: 10.1111/j.1365-2044.2010.06377.x. — View Citation
Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative complications. Cochrane Database Syst Rev. 2003;(4):CD004423. Review. — View Citation
Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015. Review. — View Citation
Hamid T, Aleem Q, Lau Y, Singh R, McDonald J, Macdonald JE, Sastry S, Arya S, Bainbridge A, Mudawi T, Balachandran K. Pre-procedural fasting for coronary interventions: is it time to change practice? Heart. 2014 Apr;100(8):658-61. doi: 10.1136/heartjnl-20 — View Citation
Kwon OK, Oh CW, Park H, Bang JS, Bae HJ, Han MK, Park SH, Han MH, Kang HS, Park SK, Whang G, Kim BC, Jin SC. Is fasting necessary for elective cerebral angiography? AJNR Am J Neuroradiol. 2011 May;32(5):908-10. doi: 10.3174/ajnr.A2408. Epub 2011 Mar 17. — View Citation
Rosengarten J, Ozkor M, Knight C. Fasting and cardiac catheterization should we be following the evidence. Controversies and Consensus in Imaging and Intervention (C2I2) 2007;V5:22-3
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite incidence of nausea, vomiting, abdominal pain, emergency intubation and aspiration | The incidence of any of nausea, vomiting, abdominal pain aspiration or emergency intubation during the procedure and up to 8 hours will be recorded. | 8 hours | |
Secondary | Incidence of hypoglycaemia | Drop of Blood sugar < 3.6 mmol/l as assessed by finger prick test before the procedure. | 1 hour | |
Secondary | Incidence of hypotension | Drop of SBP<90 mmHg and /or DBP<60 mmHg as measured by manual sphygmomanometer before the procedure. | 1 hour | |
Secondary | Patient satisfaction | A questionnaire given to the patient after the procedure to assess their experience , symptoms and overall satisfaction with regard to the procedure. The questionnaire include a preset of yes/no question including feeling hungry, thirsty or lethargic before the procedure, feeling headache, nausea or vomited during or up to 1 hour after the procedure. then a final overall satisfaction score about the procedure today from 1- 5, with 1 being not satisfied and 5 being extremely satisfied. | 1 hour | |
Secondary | chest infection | All patients will be contacted or reviewed in clinic to assess for chest infection | At 30 days |
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