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Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy (PRO-GI SAFE)

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

1000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Vietnam
      • Hanoi, Vietnam
        • Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
        • Contatto:
          • Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.
          • Numero di telefono: +084869587720
          • Email: trungtamgaymehoisuc@bachmai.edu.vn

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients undergoing Propofol-Based Diagnostic Gastrointestinal Endoscopy at Bach Mai Hospital, a tertiary referral center in Vietnam.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Droga: Propofol
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.
Procedura: Diagnostic gastrointestinal endoscopy
Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Clinically Relevant Hypotension
Lasso di tempo: 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
Lasso di tempo: 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:

  1. oxygen saturation (SpO2) <90% for at least 10 seconds; or
  2. any SpO2 <85%; or
  3. hypoxemia requiring airway or respiratory intervention, including head repositioning, chin lift, jaw thrust, increased oxygen flow, oral/nasal airway placement, bag-mask ventilation, or temporary interruption of the procedure.
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with Severe hypotension
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Discharge From the Recovery Area
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bach Mai Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

30 ottobre 2026

Date di iscrizione allo studio

Primo inviato

8 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BMH-GI-PROPOFOL-OBS-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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