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

21 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Geschat)

1000

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

Studie Locaties

  • Vietnam
      • Hanoi, Vietnam
        • Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
        • Contact:
          • Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.
          • Telefoonnummer: +084869587720
          • E-mail: trungtamgaymehoisuc@bachmai.edu.vn

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

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

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

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: 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.
Procedure: Diagnostic gastrointestinal endoscopy
Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Clinically Relevant Hypotension
Tijdsspanne: 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
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with Severe hypotension
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Discharge From the Recovery Area
Tijdsspanne: 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.

Medewerkers en onderzoekers

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

Sponsor

Bach Mai Hospital

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 (Geschat)

15 mei 2026

Primaire voltooiing (Geschat)

1 oktober 2026

Studie voltooiing (Geschat)

30 oktober 2026

Studieregistratiedata

Eerst ingediend

8 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

21 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BMH-GI-PROPOFOL-OBS-2026-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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