NCT04379141

Brief Summary

This research is expected to study ultrasonic measurement of internal jugular vein and inferior vena cava, which can be used as a good index to predict hypotension after anesthesia induction, and its measurement method is simple and quick.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 8, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

May 1, 2020

Last Update Submit

May 6, 2020

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypotension after anesthesia Induction

    Hypotension can be diagnosed if one of the following conditions is true: (1) a decrease in mean arterial pressure of \> 20% compared to the baseline value (2) mean arterial pressure \< 60mmHg

    within 12 hours after anesthesia induction

Secondary Outcomes (1)

  • Ultrasonic measurement of inferior vena cava and internal jugular vein

    within 1 hour before anesthesia induction

Study Arms (2)

hypotension

Patients with hypotension after induction of anesthesia

non-hypotension

Patients without hypotension after induction of anesthesia

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing gastrointestinal surgery in the Affiliated Hospital of Xuzhou Medical University

You may qualify if:

  • Gastrointestinal surgery
  • BMI 18\~24
  • ASA score gradeⅠ\~ III

You may not qualify if:

  • anemia
  • cirrhosis
  • Emergency surgery
  • severe hypertension
  • New York Heart Association III \~ IV or ejection fraction \<40%
  • cirrhosis
  • Other serious systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jin Dong Liu

    The Affiliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

Jin Dong Liu, M.S

CONTACT

+86-13951355136liujindong1818@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Affiliated Hospital of Xuzhou Medical University

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 7, 2020

Study Start

May 8, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share