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

15 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1617

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: xiaoyong wei, Master's degree
  • Telefoonnummer: 86-951-674-3252
  • E-mail: weixy9912@126.com

Studie Locaties

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Werving
        • General hospital of Ningxia medical university, Yinchuan, Ningxia
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: 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°.
Procedure: 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°.
Experimenteel: 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.
Procedure: 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°.
Procedure: 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°.
Experimenteel: 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.
Procedure: 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°.
Procedure: 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°.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of recovery-phase hypoxemia
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Algehele incidentie van luchtweginterventie tijdens het herstel
Tijdsspanne: Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel deelnemers dat tijdens het herstel een luchtweginterventie van welke graad dan ook nodig heeft (verhoging zuurstofstroom, kinlift, maskerbeademing of reïntubatie).
Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Ademhalingscomfortscore Tijdens Herstel
Tijdsspanne: Vanaf opname op de PACU tot ontslag, geëvalueerd tot 30 minuten
Door patiënten gerapporteerde ademhalingscomfort beoordeeld met behulp van een Numerieke Beoordelingsschaal (NRS) variërend van 0 (grootste ongemak) tot 10 (grootste comfort)
Vanaf opname op de PACU tot ontslag, geëvalueerd tot 30 minuten
Incidentie van tachycardie tijdens herstel
Tijdsspanne: Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel deelnemers dat tachycardie (hartslag >100 slagen/minuut) ervaart tijdens de herstelperiode na de procedure.
Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Incidentie van bradycardie tijdens herstel
Tijdsspanne: Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel deelnemers met bradycardie (hartslag <50 slagen/min) tijdens het herstel.
Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Incidentie van hypotensie tijdens herstel
Tijdsspanne: Van opname op de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel van deelnemers met hypotensie (systolische bloeddruk <80 mmHg) tijdens de herstelperiode.
Van opname op de PACU tot ontslag, beoordeeld tot 30 minuten
Incidentie van Misselijkheid of Braken Tijdens Herstel
Tijdsspanne: Van opname op de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel deelnemers dat misselijkheid (subjectieve klacht) of braken (objectieve uitdrijving van maaginhoud) ervaart tijdens het herstel.
Van opname op de PACU tot ontslag, beoordeeld tot 30 minuten
Incidentie van laryngospasme tijdens herstel
Tijdsspanne: Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Aandeel deelnemers dat laryngospasme (acute bovenste luchtwegobstructie met stridor/onvermogen tot ventilatie, oplossend na interventie) ervaart tijdens het herstel.
Van opname in de PACU tot ontslag, beoordeeld tot 30 minuten
Incidence of Subclinical Respiratory Depression during Recovery
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

General Hospital of Ningxia Medical University

Medewerkers

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

Onderzoekers

  • Studie stoel: Xinli Ni, Doctoral, 86-951-674-3252

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 januari 2027

Studieregistratiedata

Eerst ingediend

1 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • dywe0002

Plan Individuele Deelnemersgegevens (IPD)

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NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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