Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy (PRO-GI SAFE)
21 de mayo de 2026 actualizado por: Nguyen Toan Thang, Bach Mai Hospital
Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study
This prospective observational cohort study will evaluate the incidence and independent predictors of clinically relevant hypotension and hypoxemia during propofol-based diagnostic gastrointestinal endoscopy in adult patients at a tertiary referral hospital in Vietnam.
Participants undergoing diagnostic upper gastrointestinal endoscopy, colonoscopy, or combined diagnostic procedures with propofol administration will be followed from pre-procedure assessment through the early recovery period.
The study will assess demographic, clinical, airway, procedural, and sedation-related variables associated with clinically relevant cardiopulmonary adverse events.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Propofol is widely used for diagnostic gastrointestinal endoscopy because of its rapid onset and recovery profile, but it may be associated with cardiopulmonary adverse events, particularly hypotension and hypoxemia. The reported incidence of these events varies substantially across studies because of differences in patient populations, definitions, monitoring intensity, and sedation/anesthesia practice.
This single-center prospective cohort study will enroll adult patients undergoing diagnostic gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent. Eligible participants will be consecutively recruited at Bach Mai Hospital. Baseline demographic characteristics, comorbidities, airway assessment findings, obstructive sleep apnea risk, procedural characteristics, and sedation/anesthesia-related variables will be collected using a standardized case report form.
The two co-primary outcomes are clinically relevant hypotension and clinically relevant hypoxemia during the peri-procedural period. Participants will be monitored from pre-procedure baseline through the procedure and until discharge from the recovery area. If early post-procedure observation is prolonged because of a sedation/anesthesia-related event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.
Two separate multivariable logistic regression models will be developed to identify independent predictors of clinically relevant hypotension and clinically relevant hypoxemia. The study is intended to inform risk stratification and improve patient safety during propofol-based diagnostic gastrointestinal endoscopy
Tipo de estudio
De observación
Inscripción (Estimado)
1000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Thang Toan Nguyen, PhD
- Número de teléfono: +084916874795
- Correo electrónico: nguyentoanthang@hmu.edu.vn
Ubicaciones de estudio
-
-
-
Hanoi, Vietnam
- Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
-
Contacto:
- Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.
- Número de teléfono: +084869587720
- Correo electrónico: trungtamgaymehoisuc@bachmai.edu.vn
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled for diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy
- Planned use of propofol as the primary sedative/anesthetic agent for diagnostic gastrointestinal endoscopy
- American Society of Anesthesiologists physical status I to III
- Able to provide informed consent or has legally authorized representative consent according to local regulations
Exclusion Criteria:
- Therapeutic or interventional gastrointestinal endoscopy, including ERCP, EUS-guided intervention, EMR, ESD, endoscopic hemostasis, or polypectomy
- Planned sedation/anesthesia without propofol as the primary sedative/anesthetic agent
- Known allergy or contraindication to propofol
- Pregnancy or suspected pregnancy
- Emergency condition requiring immediate advanced airway control before the procedure
- Inability to obtain essential baseline or outcome data required for the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cohort Description
Adult patients undergoing diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent at a tertiary referral hospital.
All enrolled participants will receive standard peri-procedural monitoring and will be followed from pre-sedation assessment through discharge from the recovery area.
If early post-procedure observation is prolonged because of a sedation-related cardiopulmonary event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.
|
Propofol is the primary sedative/anesthetic agent used for diagnostic gastrointestinal endoscopy according to routine clinical practice.
The loading dose, incremental bolus doses, maintenance infusion rate if used, total dose, weight-normalized total dose, timing of administration, and any adjunct sedative or analgesic medications will be recorded as observational exposure variables.
Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Clinically Relevant Hypotension
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with clinically relevant hypotension during propofol-based diagnostic gastrointestinal endoscopy.
Clinically relevant hypotension should be defined according to the protocol-specified blood pressure threshold and duration.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of Participants With Clinically Relevant Hypoxemia
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with clinically relevant hypoxemia during propofol-based diagnostic gastrointestinal endoscopy. Clinically relevant hypoxemia should be defined according to the protocol-specified oxygen saturation threshold and duration. Clinically relevant hypoxemia is defined as at least one of the following during the peri-procedural period:
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with Severe hypotension
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with Severe hypotension, Severe hypotension is defined as mean arterial pressure <60 mmHg or systolic blood pressure <80 mmHg.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of participants with severe hypoxemia
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with severe hypoxemia.
Severe hypoxemia is defined as any oxygen saturation <85%.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of Participants Requiring Airway Intervention
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants who require any airway intervention, including head repositioning, chin lift, jaw thrust, oral or nasal airway insertion, bag-mask ventilation, or tracheal intubation.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Vasopressor use
Periodo de tiempo: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Administration of vasopressor medication to treat peri-procedural hypotension.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Discharge From the Recovery Area
Periodo de tiempo: From end of procedure to discharge from the recovery area, assessed up to 4 hours.
|
Time from end of procedure to discharge from the recovery area.
|
From end of procedure to discharge from the recovery area, assessed up to 4 hours.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de mayo de 2026
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
30 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BMH-GI-PROPOFOL-OBS-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The investigators have not yet finalized a plan for sharing individual participant data.
Any future decision will be subject to institutional approval, participant confidentiality safeguards, applicable ethics requirements, and journal or data-sharing policies in effect at the time of publication.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Propofol
-
Nurdan SağbaşActivo, no reclutandoDepresión mayor | Desorden afectivo bipolar | Depresión bipolar fase deprimidaTurquía (Türkiye)
-
Groupe Hospitalier Diaconesses Croix Saint-SimonTerminadoRecuperación de ovocitos | Procreación Médicamente Asistida (MAP)Francia
-
Hopital FochTerminado
-
Hacettepe UniversityReclutamientoSedación | Infusión de propofol controlada por objetivo | Sedación en la Unidad de Cuidados IntensivosTurquía (Türkiye)
-
Marmara University Pendik Training and Research...Aún no reclutandoDisección submucosa endoscópica | Complicaciones Respiratorias | Infusión de propofol controlada por objetivo | Unidad de Endoscopia
-
Marmara University Pendik Training and Research...ReclutamientoAnestesia Pediátrica | Agitaciones postoperatorias en pacientes pediátricos | Náuseas y vómitos posoperatorios (NVPO) | Delirio Emergente en Anestesia PediátricaTurquía (Türkiye)
-
Konkuk University Medical CenterTerminadoEnfermedad de la arteria coronaria | Enfermedad cardíaca valvularCorea, república de
-
University Medical Center GroningenTerminadoAnestesia | Inestabilidad hemodinámica | Interacción | Trastorno del transporte de oxígenoPaíses Bajos
-
Ankara City Hospital BilkentUludag UniversityTerminadoAneurisma cerebral no roto | Aneurisma intracraneal no roto | Aneurismas CerebralesTurquía (Türkiye)
-
B. Braun Melsungen AGTerminado