Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lateral decubitus position group (Group L), Supine position group (Group S).
- Кому может быть актуально
- Состояния в реестре: Postoperative Hypoxemia. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Lateral Versus Supine Positions on Postoperative Hypoxemia in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Prospective Randomized Controlled Study
Обзор
Using prospective real-world data, this study aims to determine whether the lateral decubitus position reduces the incidence of post-procedure hypoxemia in patients undergoing painless gastroscopy/colonoscopy, thereby providing a simple, non-invasive, and low-cost optimization strategy for clinical practice.
Подробное описание
Painless gastroscopy and colonoscopy have become essential modalities for the screening and diagnosis of digestive tract diseases, with their utilization increasing annually. However, hypoxemia remains the most common complication during these procedures, with reported incidences ranging widely from 1.8% to 69%. Severe hypoxemia can lead to adverse outcomes, including arrhythmias, hemodynamic decompensation, and hypoxic brain injury. Consequently, developing effective strategies to prevent hypoxemia in patients undergoing sedation for gastrointestinal (GI) endoscopy is of significant clinical value.
Current clinical research has primarily focused on hypoxemia occurring during the endoscopic procedure itself, whereas there is a paucity of high-quality evidence regarding the incidence and preventive measures of hypoxemia during the recovery phase. Specifically, the impact of body positioning on post-procedural hypoxemia remains largely unexplored. Emerging evidence suggests that the lateral decubitus position significantly reduces the incidence of hypoxemia during adult sedation. Anatomically, in the supine position, residual sedative effects combined with gravity cause the tongue and soft palate-structures lacking bony support-to collapse posteriorly, leading to upper airway obstruction. Conversely, the lateral position helps maintain a patent airway by preventing this collapse and optimizing the ventilation-perfusion (V/Q) matching, thereby stabilizing oxygenation.
Despite this theoretical basis, prospective studies investigating the effect of body positioning on recovery-phase hypoxemia in real-world settings are lacking. Therefore, this study hypothesizes that the lateral decubitus position reduces the incidence of recovery-phase hypoxemia compared to the supine position. Using prospective real-world data, we aim to validate this hypothesis and provide a simple, non-invasive, and cost-effective optimization strategy for clinical practice.
Вмешательства
- Процедура Lateral decubitus position group (Group L)
Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Lateral Group (Group L) were maintained in the predetermined left lateral p - Процедура Supine position group (Group S)
Upon admission to the Post-Anesthesia Care Unit (PACU), an independent researcher (attending anesthesiologist) assessed the patient using the Ramsay Sedation Scale (1: anxious and agitated; 2: awake, calm, and cooperative; 3: drowsy but responsive to verbal commands; 4: asleep but responsive to tactile stimulation or pain; 5: asleep with a sluggish response to stimulation; 6: deep sleep with no response). Patients in the Supine Group (Group S) were turned from the predetermined lateral position
Первичные конечные точки
- Incidence of recovery-phase hypoxemia, [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
Вторичные конечные точки (12)
- Incidence of Severe Hypoxemia During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Subclinical Respiratory Depression during Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes.]
- Overall Incidence of Airway Intervention During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Cough Severity Grade During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Length of Stay in Post-Anesthesia Care Unit (PACU) [Срок оценки: From PACU admission until discharge]
- Respiratory Comfort Score During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- PACU Nurse Satisfaction Score [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Tachycardia During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Bradycardia During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Hypotension During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Nausea or Vomiting During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
- Incidence of Laryngospasm During Recovery [Срок оценки: From PACU admission until discharge, assessed up to 30 minutes]
Критерии участия
Критерии включения
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Scheduled for combined painless esophagogastroduodenoscopy/colonoscopy or either of the two procedures.
- Ability to understand the study protocol and provide written informed consent.
- A broad set of inclusion criteria was adopted to enroll a patient population that better reflects routine clinical practice. The study aimed to enhance the generalizability of the findings by including patients with various comorbidities, such as preprocedural hypoxemia (room-air SpO₂ ≤ 90%), history of pulmonary surgery, obstructive sleep apnea (OSA), and other pulmonary conditions (including asthma, COPD, chronic bronchitis, emphysema, and pulmonary bullae).
Критерии исключения
- Severe cardiovascular or cerebrovascular diseases.
- Pregnant patients.
- History of hypersensitivity to ciprofol.
Withdrawal Criteria:
- Endotracheal intubation required during the procedure.
- Voluntary withdrawal requested by the patient or their legal representative.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- General hospital of Ningxia medical university, Yinchuan, Ningxia — Иньчуань
Идентификаторы
NCT: NCT07545642 · dywe0001