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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension; Hypoxemia
• Intervention / Treatment: Drug: Propofol; Procedure: Diagnostic gastrointestinal endoscopy

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Thang Toan Nguyen, PhD; Phone Number: +084916874795; Email: nguyentoanthang@hmu.edu.vn

Study Locations

• 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.; Phone Number: +084869587720; Email: trungtamgaymehoisuc@bachmai.edu.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinically Relevant Hypotension	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	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: oxygen saturation (SpO2) <90% for at least 10 seconds; or; any SpO2 <85%; or; 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Severe hypotension	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	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	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	Administration of vasopressor medication to treat peri-procedural hypotension.	From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discharge From the Recovery Area	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.

Collaborators and Investigators

• Sponsor: Bach Mai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; Gastrointestinal endoscopy; Upper gastrointestinal endoscopy; Procedural sedation; Prospective cohort; Hemodynamic instability; Oxygen desaturation; Propofol sedation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia; Hypotension; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: BMH-GI-PROPOFOL-OBS-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No