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Research Article: Effect of modified endotracheal intubation protocol combined with early oral intake on postoperative recovery quality in thyroid and parathyroid surgery at a tertiary hospital in China: a 2x2 factorial randomised controlled trial protocol

Date Published: 2024-01-18

Abstract:
Introduction Early oral intake (EOI) is supposed to be safe and beneficial to patients’ recovery. However, the optimal timing of resuming oral intake has not been validated in thyroid and parathyroid surgery. On the other hand, a modified electromyography (EMG) endotracheal intubation protocol with real-time EMG monitoring during video laryngoscope/fibrescope-guided intubation was presented in 2022, which was regarded as an effective way to shorten the intubation time. We aimed to use Quality of Recovery-15 (QoR-15) questionnaire to compare the efficacy and safety of different EMG endotracheal intubation protocols combined with different postoperative oral intake strategy in thyroid and parathyroid surgery. Methods and analysis This prospective, single-centre, 2×2 factorial, randomised controlled trial will be conducted in the Peking Union Medical College Hospital (PUMCH), China. We plan to recruit 200 adult patients who will receive thyroid or parathyroid surgery under intraoperative nerve monitoring. Eligible patients will be randomly divided into two groups, which will receive either the modified intubation protocol (M group) or conventional intubation process (C group). After patients enter postanaesthesia care unit and Steward scores ?4, they will be randomly divided into two groups again, which will receive early resumption of oral intake (E group) or delayed resumption of oral intake (D group). Patients will be followed up during hospitalisation and the QoR-15 questionnaire will be administered to compare the quality of recovery on the day before surgery (T 0 ), the first day after surgery (T 1 ) and the day of discharge (T 2 ). The primary outcome is the QoR-15 scores at T 1 . Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of Peking Union Medical College Hospital (IRB K-2501). All participants will give written informed consent before participation. The results from this study will be shared at conferences and disseminated in international journals. Trial registration number NCT05624463 .

Introduction:
Background and rationale Thyroid cancer is the fourth most common cancer in women in China, and the incidence continues to rise worldwide. 1 2 The surgical management was one of the most effective treatments for patients with thyroid and parathyroid diseases. 3 Since the 1990s, there has indeed been a substantial increase in ambulatory thyroidectomy, 4 5 reflecting the urgent need for accelerating the recovery of surgical patients. With the development of fast track surgery and enhanced recovery after surgery…

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