Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy
15 de junio de 2026 actualizado por: General Hospital of Ningxia Medical University
Effects of Lateral Decubitus Head-up Position, Supine Head-up Position, and Standard Lateral Decubitus Position on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Multicenter, Three-arm Randomized Controlled Trial
Through a multicenter, three-arm randomized controlled trial design, this study aimed to compare the effects of three positioning strategies-side-lying with elevated head position, supine with elevated head position, and standard side-lying position-on the incidence of hypoxemia during the recovery phase in patients undergoing painless gastroscopy and colonoscopy.
The goal was to provide clinicians with a simple, non-invasive, and cost-effective optimization strategy.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Painless gastroscopy and colonoscopy have become the gold standard for screening and diagnosing gastrointestinal diseases due to their high patient comfort and excellent compliance rates, with their clinical application expanding annually. This procedure is performed under intravenous general anesthesia to achieve painlessness; however, anesthetic agents exert inhibitory effects on the patient's respiratory center. Additionally, the procedural manipulation causes irritation to the airways and gastrointestinal tract, leading to a high incidence of hypoxemia during the postoperative recovery phase-the most common respiratory adverse event associated with painless gastroscopy and colonoscopy. Mild cases may prolong patient recovery time, while severe cases can result in serious complications such as hypoxic brain injury or cardiac arrest, directly compromising patient safety and healthcare experience.
Positioning is a critical non-pharmacological intervention factor influencing perioperative respiratory function in patients undergoing painless gastroscopy and colonoscopy. Different positions alter thoracic compliance, airway patency, and diaphragmatic position, thereby affecting the patient's ventilation and oxygenation status. Currently, the standard lateral decubitus position is routinely used for painless gastroscopy and colonoscopy, and it has been demonstrated to reduce the incidence of hypoxemia. However, this position presents challenges such as difficulties in patient monitoring and localized pressure-related discomfort. In contrast, the supine head-up and lateral decubitus head-up positions, by elevating the head and adjusting the body angle, effectively mitigate tongue base prolapse and improve thoracic expansion, theoretically reducing the risk of hypoxemia. Nevertheless, there is currently a lack of multicenter, large-sample, prospective randomized controlled studies to compare the efficacy and safety of these three positions in preventing hypoxemia in recovery rooms for painless gastroscopy and colonoscopy patients. Consequently, there is no unified evidence-based guideline for selecting the optimal clinical positioning.
Based on this, this study focuses on three clinically common positions and employs a multicenter, three-arm, randomized controlled parallel design to systematically investigate the effects of lateral supine with head elevated, supine with head elevated, and standard lateral position on postoperative hypoxemia in patients undergoing painless gastroscopy and colonoscopy. The aim is to fill a research gap in this field and provide high-quality evidence-based medical data to optimize postoperative position management during recovery and reduce adverse respiratory events following painless gastrointestinal endoscopy.
Special Note：Prespecified subgroup analyses will be conducted based on age (<65 vs ≥65), sex, BMI, ASA class, smoking and alcohol use, Mallampati score, anesthetic agent (clobupol or propofol), type of endoscopy (gastroscopy, colonoscopy, or gastroenteroscopy), Ramsay sedation score (2-4), pre-procedure hypoxemia, prior pulmonary surgery, OSA, respiratory disease, and intra-procedural hypoxemia (SpO₂ ≤90% for >10 seconds). The influence of heterogeneity on the primary outcome will also be evaluated.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1617
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: xiaoyong wei, Master's degree
- Número de teléfono: 86-951-674-3252
- Correo electrónico: weixy9912@126.com
Ubicaciones de estudio
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Ningxia
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Yinchuan, Ningxia, Porcelana, 750001
- Reclutamiento
- General hospital of Ningxia medical university, Yinchuan, Ningxia
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Contacto:
- xiaoyong wei
- Número de teléfono: 86-951-674-3252
- Correo electrónico: weixy9912@126.cm
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: lateral decubitus head-up position group (LH group)
The patient maintains the predetermined lateral position with the head of the bed elevated at 30 degrees.
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An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.
An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score.
All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.
|
|
Experimental: supine head-up position group (SH group)
The patient was transferred from a pre-existing lateral decubitus position to a supine position without a headrest, with the head of the bed elevated at 30 degrees.
|
An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score.
All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position).
Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.
|
|
Experimental: standard lateral decubitus position group (SL group)
Patients should maintain their original left lateral position with the head of the bed elevated at 0 degrees.
|
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination).
Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.
An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position.
Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response.
Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score.
Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position).
Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of recovery-phase hypoxemia
Periodo de tiempo: From PACU admission until discharge, assessed up to 30 minutes
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Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting >10 seconds) during the post-procedure recovery period
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From PACU admission until discharge, assessed up to 30 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidencia General de Intervención de la Vía Aérea Durante la Recuperación
Periodo de tiempo: Desde el ingreso en la PACU hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que requieren cualquier grado de intervención de las vías respiratorias (aumento del flujo de oxígeno, elevación del mentón, ventilación con mascarilla o reintubación) durante la recuperación.
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Desde el ingreso en la PACU hasta el alta, evaluado hasta 30 minutos
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Puntuación de Confort Respiratorio Durante la Recuperación
Periodo de tiempo: Desde el ingreso en la sala de recuperación postanestésica hasta el alta, evaluado hasta 30 minutos
|
Comodidad respiratoria informada por el paciente evaluada mediante una Escala de Calificación Numérica (ECN) que va de 0 (peor incomodidad) a 10 (mayor comodidad)
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Desde el ingreso en la sala de recuperación postanestésica hasta el alta, evaluado hasta 30 minutos
|
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Incidencia de Taquicardia Durante la Recuperación
Periodo de tiempo: Desde el ingreso en la URPA hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que experimentan taquicardia (frecuencia cardíaca >100 latidos/min) durante el período de recuperación posterior al procedimiento.
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Desde el ingreso en la URPA hasta el alta, evaluado hasta 30 minutos
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Incidencia de bradicardia durante la recuperación
Periodo de tiempo: Desde el ingreso en la URA hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que experimentan bradicardia (frecuencia cardíaca <50 latidos/min) durante la recuperación.
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Desde el ingreso en la URA hasta el alta, evaluado hasta 30 minutos
|
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Incidencia de Hipotensión Durante la Recuperación
Periodo de tiempo: Desde el ingreso en la PACU hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que experimentaron hipotensión (presión arterial sistólica <80 mmHg) durante la recuperación.
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Desde el ingreso en la PACU hasta el alta, evaluado hasta 30 minutos
|
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Incidencia de Náuseas o Vómitos Durante la Recuperación
Periodo de tiempo: Desde el ingreso en la UCPA hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que experimentan náuseas (queja subjetiva) o vómitos (expulsión objetiva de contenidos gástricos) durante la recuperación.
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Desde el ingreso en la UCPA hasta el alta, evaluado hasta 30 minutos
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Incidencia de laringoespasmo durante la recuperación
Periodo de tiempo: Desde el ingreso en la URPA hasta el alta, evaluado hasta 30 minutos
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Proporción de participantes que experimentan laringoespasmo (obstrucción aguda de las vías respiratorias superiores con estridor/incapacidad para ventilar, que se resuelve con intervención) durante la recuperación.
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Desde el ingreso en la URPA hasta el alta, evaluado hasta 30 minutos
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Incidence of Subclinical Respiratory Depression during Recovery
Periodo de tiempo: From PACU admission until discharge, assessed up to 30 minutes.
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Proportion of participants experiencing subclinical respiratory depression, defined as any episode of pulse oxygen saturation (SpO₂) in the range of 90% to <95% (inclusive of 90%, exclusive of 95%) during the post-procedure recovery period
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From PACU admission until discharge, assessed up to 30 minutes.
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Cough Severity Grade During Recovery
Periodo de tiempo: From PACU admission until discharge, assessed up to 30 minutes
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Severity of cough assessed during the recovery period, graded as: Grade I: No cough, smooth breathing; Grade II: Single mild cough; Grade III: Multiple coughs lasting <15 seconds; Grade IV: Continuous coughing lasting ≥15 seconds.
Reported as the proportion of participants reaching each grade (I-IV).
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From PACU admission until discharge, assessed up to 30 minutes
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Length of Stay in Post-Anesthesia Care Unit (PACU)
Periodo de tiempo: From PACU admission until discharge, assessed up to 30 minutes
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Time from admission to the post-anesthesia care unit (PACU) until discharge criteria are met (modified Aldrete score ≥9 on three consecutive assessments), recorded in minutes.
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From PACU admission until discharge, assessed up to 30 minutes
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PACU Nurse Satisfaction Score
Periodo de tiempo: From PACU admission until discharge, assessed up to 30 minutes
|
Nurse-assessed satisfaction with patient respiratory stability and overall recovery management, rated using a Numerical Rating Scale (NRS) ranging from 0 (lowest satisfaction) to 10 (highest satisfaction), recorded at patient discharge from the post-anesthesia care unit
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From PACU admission until discharge, assessed up to 30 minutes
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Xinli Ni, Doctoral, 86-951-674-3252
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- dywe0002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .