Continuous BP Monitoring During Sedation for Endoscopy

Continuous Noninvasive Blood Pressure Monitoring During Sedation for High-Risk Patients Undergoing Gastrointestinal Endoscopy

This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using to continuous noninvasive blood pressure measurement. The study is designed to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.

Study Overview

• Status: Not yet recruiting
• Conditions: High-Risk Patients Undergoing Gastrointestinal Endoscopy
• Intervention / Treatment: Device: continuous noninvasive blood pressure monitoring

Detailed Description

This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using an oscillometric arm cuff to continuous noninvasive blood pressure measurement on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.

The primary aim is to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension. The secondary aims are to evaluate the impact of continuous blood pressure monitoring on total IV fluid administered, total vasopressor administered, intra-operative depth of sedation, post-operative nausea and vomiting (PONV), and the time to discharge readiness.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Neal Fleming, MD, PhD; Phone Number: 916 734-5028; Email: nwfleming@health.ucdavis.edu
• Study Contact Backup: Name: David Asseff, MD; Phone Number: 916 734-5028; Email: dasseff@healt.ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High-Risk Patients Undergoing Gastrointestinal Endoscopy

Description

Inclusion Criteria:

• Age ≥ 50 years
• American Society of Anesthesiologists (ASA) Physical Status ≥ 3
• Scheduled for upper or lower endoscopic procedure with planned propofol administration
• Planned oscillometric blood pressure monitoring using arm cuff without an arterial pressure catheter.

Exclusion Criteria:

• Age <50 years
• ASA Physical Status 1 or 2
• Patients known to be pregnant
• Patients with an existing arterial pressure catheter
• Patients on mechanical circulatory support
• Patients with planned intubation for procedure
• Patients with a difference in systolic blood pressure measurement between right and left upper extremities > 10 mmHg
• Patients with extreme contraction of the smooth muscle in the arteries and arterioles of the arm and hand, such as may be present with Raynaud's disease
• Patients with an inability to place the noninvasive finger cuffs due to anatomy, skin condition, or obstructive paraphernalia (such as false nails)

Study Plan

How is the study designed?

Design Details

• Observational Models: CASE_CONTROL
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High-Risk Patients Undergoing Gastrointestinal Endoscopy; Patients scheduled for elective endoscopic procedures	Device: continuous noninvasive blood pressure monitoring; continuous noninvasive blood pressure monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	Mean Arterial Pressure (MAP) < 65 mmHg for a total duration ≥ 5 minutes	during procedure and post-procedure recovery period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total IV fluid administered	Volume in ml/kg/hr	during procedure and post-procedure recovery period
total vasopressor administered	Total doses in mg/kg	during procedure and post-procedure recovery period
intra-operative depth of sedation	Patient State Index (PSI), mean, min, max	during procedure and post-procedure recovery period
post-operative nausea and vomiting	Incidence requiring treatment	during procedure and post-procedure recovery period
time to discharge readiness	Time from Post-Anesthesia Care Unit (PACU) admission to Aldrete Score=10	during procedure and post-procedure recovery period

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Study Director: Neal Fleming, MD, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Estimated): November 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 23, 2026
• First Submitted That Met QC Criteria: November 5, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 5, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Hypotension, endoscopy, continuous blood pressure monitoring
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2465371

Plan for Individual participant data (IPD)

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

IPD Plan Description

Confidentiality requirements require review

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No