NCT05954832

Brief Summary

The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jul 2023Jul 2027

First Submitted

Initial submission to the registry

July 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

July 13, 2023

Last Update Submit

January 28, 2026

Conditions

Anesthesia

Keywords

Changes in Heart FunctionChanges in Blood FlowEchocardiography23-079

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with post-induction hypotension (PIH)

    summarize the distributions of the echocardiography parameter values (pre-load LVEDd(cm), after-load LVEDs(cm), other measures \[e.g., contractility (EF %) and structural abnormalities\]) across each timepoint among patients with and without PIH

    up to 20-mins after anesthesia induction.

Study Arms (1)

Echocardiography

Patients participating in this study will undergo routine anesthetic and perioperative care with the addition of an echocardiography and Clearsight BP measurement.

Diagnostic Test: Echocardiography

Interventions

EchocardiographyDIAGNOSTIC_TEST

Echocardiography and Clearsight BP measurements before, immediately after anesthesia induction and after intubation (for 20 min)

Echocardiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients requiring general anesthesia for surgery

You may qualify if:

  • Adult patients ≥ 18 years of age requiring general anesthesia for surgery
  • Intubation required for anesthetic management / surgery
  • Anticipated prep time before incision of 20 minutes
  • Baseline MAP \>70mmHg

You may not qualify if:

  • History of coronary artery disease
  • History of cardiac disease (e.g., HTN, arrythmias, valvular and structural abnormalities)
  • History of peripheral artery occlusive disease
  • Beta-blocker use
  • Anti-hypertensive medication use
  • Patients with epidural, spinal, paravertebral, serratus blocks preoperatively
  • Patients requiring rapid sequence induction (where intubation occurs concurrently with induction)
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All protocol activites)

New York, New York, 10065, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Anahita Dabo-Trubelja, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Dabo-Trubelja, MD

CONTACT

212-639-3279daboa@mskcc.org

Gregory Fischer, MD

CONTACT

212-639-2581

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 20, 2023

Study Start

July 13, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(1)