Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

15 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

1617

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: xiaoyong wei, Master's degree
  • Número de telefone: 86-951-674-3252
  • E-mail: weixy9912@126.com

Locais de estudo

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Recrutamento
        • General hospital of Ningxia medical university, Yinchuan, Ningxia
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Procedimento: 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°.
Procedimento: 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.
Procedimento: 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°.
Procedimento: 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.
Procedimento: 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°.
Procedimento: 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°.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of recovery-phase hypoxemia
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidência Global de Intervenção das Vias Aéreas Durante a Recuperação
Prazo: Desde a admissão na URPA até à alta, avaliado até 30 minutos
Proporção de participantes que necessitam de qualquer grau de intervenção nas vias aéreas (aumento do fluxo de oxigénio, elevação do queixo, ventilação com máscara ou reintubação) durante a recuperação.
Desde a admissão na URPA até à alta, avaliado até 30 minutos
Pontuação de Conforto Respiratório Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Conforto respiratório reportado pelo paciente avaliado com uma Escala de Avaliação Numérica (EAN) que varia de 0 (pior desconforto) a 10 (maior conforto)
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidência de Taquicardia Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Proporção de participantes que experienciaram taquicardia (frequência cardíaca >100 batimentos/minuto) durante o período de recuperação pós-procedimento.
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidência de Bradicardia Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Proporção de participantes que experienciaram bradicardia (frequência cardíaca <50 batimentos/min) durante a recuperação.
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidência de Hipotensão Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Proporção de participantes que apresentam hipotensão (pressão arterial sistólica <80 mmHg) durante a recuperação.
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidência de Náuseas ou Vómitos Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Proporção de participantes que experienciam náuseas (queixa subjetiva) ou vómitos (expulsão objetiva do conteúdo gástrico) durante a recuperação.
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidência de Laringoespasmo Durante a Recuperação
Prazo: Desde a admissão na PACU até à alta, avaliado até 30 minutos
Proporção de participantes que experienciaram laringospasmo (obstrução aguda das vias aéreas superiores com estridor/incapacidade de ventilar, resolvido com intervenção) durante a recuperação.
Desde a admissão na PACU até à alta, avaliado até 30 minutos
Incidence of Subclinical Respiratory Depression during Recovery
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

General Hospital of Ningxia Medical University

Colaboradores

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

Investigadores

  • Cadeira de estudo: Xinli Ni, Doctoral, 86-951-674-3252

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de maio de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • dywe0002

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever