Preoperative fasting has been practiced prior to cardiac interventions such as cardiac implantable electronic device (CIED) procedures for 4-6 h since their inceptions. However, there is no data available on safety and efficacy of a non-fasting strategy for these procedures.
Strict fasting restrictions may be difficult for patients to abide by, and might even be detrimental to overall patient health and recovery. According to previous studies real fasting times are much longer than 4-6h in clinical practice. Prolonged fasting can lead to patient dissatisfaction as well as affect patient health through increased trauma response or changes in patient medication. Strict fasting regulations also hinder rescheduling patients in case of sudden schedule changes or new patient arrivals .
Fasting is practiced before procedures due to a fear of vomiting and aspiration, and the associated aspiration pneumonia. This was first described by Curtis Lester Mendelson as the Mendelson-syndrome in 1946.
Since then, fasting protocols have been implemented with varying lengths, and have only been remedied slightly even though modern medicine has improved greatly in regards to treating complications from aspiration. CIED implantations also don’t use regular deep sedation for their procedures, but fasting is still often practiced for 6 hours prior to procedures with very little evidence to support this practice.
In our investigator-driven, prospective, parallel-group, and single-arm blinded Fast-CIED trial we randomized 201 patients undergoing elective CIED implantations in a tertiary high-volume center into two groups (NCT04389697). Patients were assigned to a non-fasting strategy (100 patients, solids/fluids allowed up to 1h) or a fasting strategy (101 patients, at least 6h no solids and 2h no fluids) before the procedure and analyzed on an intention-to-treat basis. The co-primary outcomes were patients’ wellbeing scores (based on numeric rating scale, NRS 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration and emergency intubation. Renal, hematologic and metabolic blood parameters and 30-day follow-up data were gathered.
The summed pre-procedural patients’ wellbeing score was significantly lower (i.e. better) in the Non-fasting group (Non-fasting: 13.1±9.6 vs. Fasting: 16.5±11.4, 95%CI of Mean Difference (MD) -6.35 - -0.46, P=0.029), which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (Non-fasting versus Fasting; hunger: 0.9±1.9 versus 3.1±3.2, 95% CI of MD -2.86 – -1.42, p < 0.001; tiredness: 1.6±2.3 versus 2.6±2.7, 95% CI of MD -1.68 – -0.29, P=0.023). No intra-procedural food related adverse events were observed. Relevant blood parameters and 30-day follow-up didn’t show significant differences. The study also showed that, in daily practice, fasting times for patients were longer than intended (5.20 ± 4.88 hours and 12.63 ± 6.36 hours for the non-fasting and fasting groups, respectively (P<0.001)) mainly due to standardized meal serving times in hospitals regardless of procedure starting times and short-term schedule changes.
The Fast-CIED Study was the first randomized clinical trial to assess the benefits of a non-fasting compared to a fasting strategy before elective cardiac implantable electronic device (CIED) procedures. It showed that a non-fasting strategy is beneficial to a fasting strategy regarding patients’ wellbeing and comparable in terms of safety for CIED-procedures, allowing optimized procedure scheduling with high patient satisfaction. Our Fast-CIED trial made an important step to show that a non-fasting strategy is a viable alternative to a fasting strategy in patients undergoing elective CIED-surgery.:1. Introduction 4
1.1. Purpose of this study 4
1.2. History of preoperative fasting 5
1.3. Modern Practices 7
2. Publication 11
3. Summary/Synopsis 21
4. References 25
5. Spezifizierung des eigenen Beitrags 27
6. Erklärung über die eigenständige Abfassung der Arbeit 29
7. Lebenslauf 30
8. Danksagung 31
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:90340 |
| Date | 06 March 2024 |
| Creators | Gerhards, Matthias |
| Contributors | Universität Leipzig |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/acceptedVersion, doc-type:doctoralThesis, info:eu-repo/semantics/doctoralThesis, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
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