Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy
15 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
1617
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: xiaoyong wei, Master's degree
- Numéro de téléphone: 86-951-674-3252
- E-mail: weixy9912@126.com
Lieux d'étude
-
-
Ningxia
-
Yinchuan, Ningxia, Chine, 750001
- Recrutement
- General hospital of Ningxia medical university, Yinchuan, Ningxia
-
Contact:
- xiaoyong wei
- Numéro de téléphone: 86-951-674-3252
- E-mail: weixy9912@126.cm
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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°.
|
|
Expérimental: 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°.
|
|
Expérimental: 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°.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of recovery-phase hypoxemia
Délai: From PACU admission until discharge, assessed up to 30 minutes
|
Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting >10 seconds) during the post-procedure recovery period
|
From PACU admission until discharge, assessed up to 30 minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence globale d'intervention des voies aériennes pendant la récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants nécessitant une intervention des voies aériennes de n'importe quel grade (augmentation du débit d'oxygène, soulèvement du menton, ventilation au masque ou réintubation) pendant la récupération.
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Score de Confort Respiratoire Pendant la Récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Confort respiratoire rapporté par le patient évalué à l'aide d'une échelle d'évaluation numérique (NRS) allant de 0 (inconfort maximal) à 10 (confort maximal)
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence de tachycardie pendant la récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants présentant une tachycardie (fréquence cardiaque >100 battements/min) pendant la période de récupération post-intervention.
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence de la bradycardie pendant la récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants présentant une bradycardie (fréquence cardiaque <50 battements/min) pendant la récupération.
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence d'hypotension pendant la période de récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants présentant une hypotension (pression artérielle systolique <80 mmHg) pendant la récupération.
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence de nausées ou de vomissements pendant la récupération
Délai: De l'admission à la SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants présentant des nausées (plainte subjective) ou des vomissements (expulsion objective du contenu gastrique) pendant la récupération.
|
De l'admission à la SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence de Laryngospasme Pendant la Récupération
Délai: De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
Proportion de participants présentant un laryngospasme (obstruction aiguë des voies respiratoires supérieures avec stridor/impossibilité de ventiler, se résolvant après intervention) pendant la récupération.
|
De l'admission en SSPI jusqu'à la sortie, évalué jusqu'à 30 minutes
|
|
Incidence of Subclinical Respiratory Depression during Recovery
Délai: From PACU admission until discharge, assessed up to 30 minutes.
|
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
|
From PACU admission until discharge, assessed up to 30 minutes.
|
|
Cough Severity Grade During Recovery
Délai: From PACU admission until discharge, assessed up to 30 minutes
|
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).
|
From PACU admission until discharge, assessed up to 30 minutes
|
|
Length of Stay in Post-Anesthesia Care Unit (PACU)
Délai: From PACU admission until discharge, assessed up to 30 minutes
|
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.
|
From PACU admission until discharge, assessed up to 30 minutes
|
|
PACU Nurse Satisfaction Score
Délai: 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
|
From PACU admission until discharge, assessed up to 30 minutes
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chaise d'étude: Xinli Ni, Doctoral, 86-951-674-3252
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 mai 2026
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
31 janvier 2027
Dates d'inscription aux études
Première soumission
1 mai 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- dywe0002
Plan pour les données individuelles des participants (IPD)
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NON
Informations sur les médicaments et les dispositifs, documents d'étude
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