Coronary Artery Disease Clinical Trial
— FORCEOfficial title:
Fasting or Non-fasting Before Cardiac Catheterization
NCT number | NCT05133206 |
Other study ID # | 303042 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2022 |
Est. completion date | October 2023 |
The investigators hypothesise that there is no increased risk of peri-procedural complications, accompanied by improved patient satisfaction among patients allowed to eat up to the point of coronary angiography/angioplasty compared to patients, kept nil by mouth. Therefore, the investigators aim to change the practice of fasting for all patients before elective catheterization procedures. Consented patients will be randomised in a 1:1 ratio to either fasting (standard hospital fasting policy) or non-fasting (allowed to eat and drink freely up to the point of transfer to the Catheter Laboratory). Primary End Point will composite peri-procedural nausea, vomiting, pre-procedural hypotension, pre-procedural hypoglycemia, intra-procedural emergency endotracheal intubation and aspiration pneumonia. This will be calculated as the number of patients experiencing at least one event. Secondary end-points will include patient satisfaction questionnaire and the individual outcomes assessed in the primary end point.
Status | Not yet recruiting |
Enrollment | 420 |
Est. completion date | October 2023 |
Est. primary completion date | August 2023 |
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 in the 2 months window from consent. Exclusion Criteria: - Patients undergoing other cardiac procedures simultaneously such as EP studies, pacing and structural heart disease intervention. - Emergency primary percutaneous coronary intervention. - Vulnerable groups (children under 18 years old, pregnancy, mental health problems that render them unable to give informed consent). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Blackpool Victoria Hospital | Blackpool | Lancashire |
Lead Sponsor | Collaborator |
---|---|
Blackpool Victoria Hospital |
United Kingdom,
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. Erratum in: Ann Emerg Med. 2017 Nov;70(5):758. — 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-2013-305289. Epub 2014 Feb 12. — 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
Naidu SS, Abbott JD, Bagai J, Blankenship J, Garcia S, Iqbal SN, Kaul P, Khuddus MA, Kirkwood L, Manoukian SV, Patel MR, Skelding K, Slotwiner D, Swaminathan RV, Welt FG, Kolansky DM. SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):255-276. doi: 10.1002/ccd.29744. Epub 2021 May 19. — View Citation
Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of nausea. | incidence of self-reported nausea measured on a binary scale (yes or no) | Within 4 hours after the procedure. | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of vomiting. | Incidence of vomiting assessed on binary scale (yes or no). | Within 4 hours after the procedure. | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of pre-procedural hypotension. | Pre-procedural hypotension (systolic blood pressure <90 mmHg and /or diastolic blood pressure < 60 mmHg as measured non-invasively by sphygmomanometer) | Within 2 hours before the procedure. | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence pre-procedural hypoglycemia. | Incidence of hypoglycemia peri-procedure (blood sugar < 3.6 mmol/l) as assessed by finger prick test. | Within 2 hours before the procedure. | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of emergency endotracheal intubation. | Incidence of emergency tracheal intubation for respiratory failure | During the procedure | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by occurrence of aspiration pneumonia. | Clinically and radiologically(X-ray and /or CT-scan) confirmed aspiration pneumonia. | During the procedure | |
Secondary | Patient satisfaction assessed by questionnaire using a binary score (YES or NO), qualitative assessment of free text comments and presence of other symptoms as listed in the Description | Questionnaire assessing the self-reported pre-procedural hunger, thirst/dry mouth, headache, weakness/lethargy, heartburn, dizziness, low mood/anxiety, ability to focus/stay mentally sharp and preferences regarding fasting on a binary scale (yes or no). | Within 4 hours after the procedure |
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