Yan Lijuan, Wang Xiao, Du Kairong, Liang Ying
Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Department of Ultrasound, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Front Med (Lausanne). 2023 Sep 14;10:1269486. doi: 10.3389/fmed.2023.1269486. eCollection 2023.
Obese patients who undergo painless gastroscopy are particularly prone to suffer from upper airway obstruction, respiratory depression, and subsequent hypoxemia. Despite adequate preoxygenation, the incidence of hypoxemia remains high. Recently, inspiratory muscle training (IMT) has been considered to be a promising strategy to increase respiratory muscle strength and endurance with the attendant improvement of pulmonary function. However, it remains unclear whether IMT is associated with a lower rate of hypoxemia in obese patients during this sedative procedure. This study aims to investigate the effectiveness of IMT used in obese patients who are scheduled for selective painless gastroscopy.
This prospective, randomized controlled trial (RCT) will enroll 232 obese patients with a body mass index (BMI) of 35-39.9 kg·m who undergo painless gastroscopy at the First Affiliated Hospital of Xiamen University. Subjects will be randomly assigned to two groups with a 1:1 ratio. Participants in both groups will receive IMT for 4 weeks prior to gastroscopy. The intervention group will receive IMT with a load of 30% of the maximal inspiratory pressure (Pi(max)) in the first week, with an increase of 10% per week since the following week, while the counterparts in the control group will not receive any load during the 4-week IMT. The primary outcome is the incidence of hypoxemia during painless gastroscopy. Secondary outcomes include the need for airway maneuvers, blood pressure changes, sleep quality assessment, pro-inflammatory cytokines levels, and monitoring of adverse events.
The outcomes of this study will offer invaluable guidance for the clinical implementation of IMT as a potential non-invasive preventive measure. Additionally, it stands to enrich our comprehension of anesthesia management and airway-related challenges in obese patients undergoing procedural sedation, which we anticipate will further contribute to addressing the turnaround concerns within high-volume, swiftly paced ambulatory endoscopy centers.
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University (2022, No.091). The results will be submitted for publication in peer-reviewed journals.
China Clinical Trial Center (ChiCTR2200067041).
接受无痛胃镜检查的肥胖患者特别容易出现上呼吸道梗阻、呼吸抑制及随后的低氧血症。尽管进行了充分的预给氧，但低氧血症的发生率仍然很高。最近，吸气肌训练（IMT）被认为是一种有前景的策略，可增加呼吸肌力量和耐力，并随之改善肺功能。然而，在这种镇静操作过程中，IMT是否与肥胖患者较低的低氧血症发生率相关尚不清楚。本研究旨在调查IMT用于计划进行选择性无痛胃镜检查的肥胖患者的有效性。
这项前瞻性随机对照试验（RCT）将纳入232名体重指数（BMI）为35-39.9kg·m²、在厦门大学附属第一医院接受无痛胃镜检查的肥胖患者。受试者将按1:1的比例随机分为两组。两组参与者在胃镜检查前均接受4周的IMT。干预组在第一周接受负荷为最大吸气压（Pi(max)）30%的IMT，从第二周起每周增加10%，而对照组在4周的IMT期间不接受任何负荷。主要结局是无痛胃镜检查期间低氧血症的发生率。次要结局包括气道操作的必要性、血压变化、睡眠质量评估、促炎细胞因子水平以及不良事件监测。
本研究的结果将为IMT作为一种潜在的非侵入性预防措施的临床应用提供宝贵的指导。此外，它有助于丰富我们对肥胖患者在接受程序性镇静时麻醉管理和气道相关挑战的理解，我们预计这将进一步有助于解决大容量、节奏快的门诊内镜中心的周转问题。
本研究已获得厦门大学附属第一医院伦理委员会批准（2022，No.091）。研究结果将提交至同行评审期刊发表。
中国临床试验中心（ChiCTR2200067041）
