Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy
7. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
1617
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: xiaoyong wei, Master's degree
- Telefonní číslo: 86-951-674-3252
- E-mail: weixy9912@126.com
Studijní místa
-
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Ningxia
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Yinchuan, Ningxia, Čína, 750001
- Nábor
- General hospital of Ningxia medical university, Yinchuan, Ningxia
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Kontakt:
- xiaoyong wei
- Telefonní číslo: 86-951-674-3252
- E-mail: weixy9912@126.cm
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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°.
|
|
Experimentální: 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°.
|
|
Experimentální: 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°.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence of recovery-phase hypoxemia
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Celkový výskyt zásahu do dýchacích cest během zotavení
Časové okno: Od přijetí na JIP do propuštění, hodnoceno až 30 minut
|
Podíl účastníků vyžadujících jakýkoli stupeň zásahu do dýchacích cest (zvýšení průtoku kyslíku, zvednutí brady, ventilaci maskou nebo reintubaci) během zotavení.
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Od přijetí na JIP do propuštění, hodnoceno až 30 minut
|
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Skóre respirační pohody během rekonvalescence
Časové okno: Od přijetí do jednotky pooperační péče až po propuštění, hodnoceno až 30 minut
|
Komfort dýchání hlášený pacientem hodnocený pomocí numerické hodnotící škály (NRS) v rozmezí od 0 (nejhorší nepohodlí) do 10 (největší komfort)
|
Od přijetí do jednotky pooperační péče až po propuštění, hodnoceno až 30 minut
|
|
Výskyt tachykardie během rekonvalescence
Časové okno: Od přijetí na oddělení pooperační péče až po propuštění, hodnoceno až 30 minut
|
Podíl účastníků, u kterých se během pooperačního zotavovacího období vyskytla tachykardie (srdeční frekvence >100 tepů/min).
|
Od přijetí na oddělení pooperační péče až po propuštění, hodnoceno až 30 minut
|
|
Výskyt bradykardie během rekonvalescence
Časové okno: Od přijetí na JIP až do propuštění, hodnoceno až 30 minut
|
Podíl účastníků s bradykardií (tepová frekvence <50 tepů/min) během rekonvalescence.
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Od přijetí na JIP až do propuštění, hodnoceno až 30 minut
|
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Výskyt hypotenze během rekonvalescence
Časové okno: Od přijetí do PACU až do propuštění, hodnoceno po dobu až 30 minut
|
Podíl účastníků, u kterých se během zotavení vyskytla hypotenze (systolický krevní tlak <80 mmHg).
|
Od přijetí do PACU až do propuštění, hodnoceno po dobu až 30 minut
|
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Výskyt nevolnosti nebo zvracení během rekonvalescence
Časové okno: Od přijetí do PACU do propuštění, hodnoceno až 30 minut
|
Podíl účastníků, kteří během zotavování zažívají nevolnost (subjektivní obtíž) nebo zvracení (objektivní vyloučení žaludečního obsahu).
|
Od přijetí do PACU do propuštění, hodnoceno až 30 minut
|
|
Výskyt laryngospasmu během zotavení
Časové okno: Od přijetí na JIP až do propuštění, hodnoceno až 30 minut
|
Podíl účastníků, u kterých se během zotavování vyskytl laryngospasmus (akutní obstrukce horních cest dýchacích se stridorem/neschopnost ventilace, která se vyřeší zásahem).
|
Od přijetí na JIP až do propuštění, hodnoceno až 30 minut
|
|
Incidence of Subclinical Respiratory Depression during Recovery
Časové okno: 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.
|
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Cough Severity Grade During Recovery
Časové okno: 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).
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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)
Časové okno: 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
|
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PACU Nurse Satisfaction Score
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Xinli Ni, Doctoral, 86-951-674-3252
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
12. května 2026
Primární dokončení (Odhadovaný)
31. prosince 2026
Dokončení studie (Odhadovaný)
31. ledna 2027
Termíny zápisu do studia
První předloženo
1. května 2026
První předloženo, které splnilo kritéria kontroly kvality
7. května 2026
První zveřejněno (Aktuální)
14. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
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