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

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1617

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

  • Kina
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750001
        • Rekruttering
        • General hospital of Ningxia medical university, Yinchuan, Ningxia
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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°.
Eksperimentel: 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°.
Eksperimentel: 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°.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of recovery-phase hypoxemia
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet forekomst af luftvejsintervention under opvågningsfasen
Tidsramme: Fra indlæggelse på PACU til udskrivelse, vurderet op til 30 minutter
Andel af deltagere, der kræver enhver grad af luftvejsintervention (øget iltflow, hage løft, maske ventilation eller reintubation) under genopretningen.
Fra indlæggelse på PACU til udskrivelse, vurderet op til 30 minutter
Respiratorisk Komfortscore Under Genopretning
Tidsramme: Fra PACU-indlæggelse til udskrivning, vurderet i op til 30 minutter
Patientrapporteret respiratorisk komfort vurderet ved hjælp af en numerisk vurderingsskala (NRS), der spænder fra 0 (værst ubehag) til 10 (størst komfort)
Fra PACU-indlæggelse til udskrivning, vurderet i op til 30 minutter
Forekomst af takykardi under rekonvalescens
Tidsramme: Fra indlæggelse på opvågning til udskrivelse, vurderet i op til 30 minutter
Andel af deltagere, der oplever takykardi (hjertefrekvens >100 slag/minut) i genopretningsperioden efter proceduren.
Fra indlæggelse på opvågning til udskrivelse, vurderet i op til 30 minutter
Forekomst af bradykardi under genopretning
Tidsramme: Fra PACU-indlæggelse til udskrivelse, vurderet op til 30 minutter
Andel af deltagere, der oplever bradykardi (hjertefrekvens <50 slag/min) under genopretningen.
Fra PACU-indlæggelse til udskrivelse, vurderet op til 30 minutter
Forekomst af hypotension under udtømning
Tidsramme: Fra optagelse på opvågningsafdeling til udskrivelse, vurderet op til 30 minutter
Andel af deltagere, der oplever hypotension (systolisk blodtryk <80 mmHg) under genopretningen.
Fra optagelse på opvågningsafdeling til udskrivelse, vurderet op til 30 minutter
Forekomst af kvalme eller opkastning under rekonvalescensen
Tidsramme: Fra optagelse på opvågningen til udskrivelse, vurderet i op til 30 minutter
Andel af deltagere, der oplever kvalme (subjektiv klage) eller opkastning (objektiv udstødning af maveindhold) under bedring.
Fra optagelse på opvågningen til udskrivelse, vurderet i op til 30 minutter
Forekomsten af laryngospasme under opvågningen
Tidsramme: Fra indlæggelse i PACU til udskrivelse, vurderet i op til 30 minutter
Andel af deltagere, der oplever laryngospasme (akut overluftvejsobstruktion med stridor/umulighed for ventilation, der ophører med intervention) under opvågningen.
Fra indlæggelse i PACU til udskrivelse, vurderet i op til 30 minutter
Incidence of Subclinical Respiratory Depression during Recovery
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

General Hospital of Ningxia Medical University

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

12. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

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