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Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy

7. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1617

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: xiaoyong wei, Master's degree
  • Telefonnummer: 86-951-674-3252
  • E-Mail: weixy9912@126.com

Studienorte

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Rekrutierung
        • General hospital of Ningxia medical university, Yinchuan, Ningxia
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Both sexes.
  3. American Society of Anesthesiologists (ASA) physical status classification I-III.
  4. Scheduled for combined painless esophagogastroduodenoscopy/colonoscopy or either of the two procedures.
  5. Ability to understand the study protocol and provide written informed consent.
  6. 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:

  1. Severe cardiovascular or cerebrovascular diseases.
  2. Pregnant patients.
  3. History of hypersensitivity to ciprofol.

Withdrawal Criteria:

  1. Endotracheal intubation required during the procedure.
  2. Voluntary withdrawal requested by the patient or their legal representative.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: supine head-up position (SH group)
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°.
Verfahren: standard lateral decubitus position group (SL group)
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.
Verfahren: standard lateral decubitus position group (SL group)
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°.
Verfahren: lateral decubitus head-up position (LH group)
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.
Verfahren: supine head-up position (SH group)
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°.
Verfahren: lateral decubitus head-up position (LH group)
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°.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of recovery-phase hypoxemia
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Gesamtinzidenz von Atemwegsinterventionen während der Erholung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet für bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase eine Atemwegsintervention jeglichen Grades benötigen (Sauerstofffluss erhöhen, Kinn anheben, Maskenbeatmung oder Reintubation).
Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet für bis zu 30 Minuten
Atemkomfort-Score während der Erholung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Die von den Patienten berichtete respiratorische Komfort wurde anhand einer numerischen Bewertungsskala (NRS) bewertet, die von 0 (schlimmster Unkomfort) bis 10 (größter Komfort) reicht.
Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Inzidenz von Tachykardie während der Erholung
Zeitfenster: Von der Aufnahme in den PACU bis zur Entlassung, bewertet für bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase nach dem Eingriff Tachykardie (Herzfrequenz >100 Schläge/Minute) erleben.
Von der Aufnahme in den PACU bis zur Entlassung, bewertet für bis zu 30 Minuten
Inzidenz von Bradykardie während der Erholung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, beurteilt für bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase Bradykardie (Herzfrequenz <50 Schläge/min) erfahren.
Von der Aufnahme in den Aufwachraum bis zur Entlassung, beurteilt für bis zu 30 Minuten
Häufigkeit von Hypotonie während der Genesung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase eine Hypotonie (systolischer Blutdruck <80 mmHg) erleben.
Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Inzidenz von Übelkeit oder Erbrechen während der Genesung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase Übelkeit (subjektive Beschwerde) oder Erbrechen (objektive Ausstoßung von Mageninhalt) erleben.
Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Inzidenz von Laryngospasmus während der Erholung
Zeitfenster: Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Anteil der Teilnehmer, die während der Erholungsphase einen Laryngospasmus (akute obere Atemwegsobstruktion mit Stridor/Unfähigkeit zu beatmen, der durch Intervention behoben wird) erleben.
Von der Aufnahme in den Aufwachraum bis zur Entlassung, bewertet bis zu 30 Minuten
Incidence of Subclinical Respiratory Depression during Recovery
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

General Hospital of Ningxia Medical University

Mitarbeiter

Wuzhong City People's Hospital
Yinchuan Traditional Chinese Medicine Hospital
Guyuan Municipal People's Hospital
Zhongwei City People's Hospital
Shizuishan City People's Hospital
Zhongwei City Traditional Chinese Medicine Hospital
Pingluo County People's Hospital
Tongxin County People's Hospital
Yanchi County People's Hospital
Zhongning County People's Hospital
Lingwu City People's Hospital
Qingtongxia City People's Hospital

Ermittler

  • Studienstuhl: Xinli Ni, Doctoral, 86-951-674-3252

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

12. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

1. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • dywe0002

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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