NCT04850092

Brief Summary

During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

April 14, 2021

Last Update Submit

September 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic arterial elastance before positional change

    Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change

    1 minute before positional change

Study Arms (2)

Non-hypotensive

Mean blood pressure is maintained after positional change from supine to prone.

Other: Positional change from supine to prone

Hypotensive

Mean blood pressure decrease \< 20% after positional change from supine to prone.

Other: Positional change from supine to prone

Interventions

Patient is turned from supine to prone position for spine surgery

HypotensiveNon-hypotensive

Eligibility Criteria

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

Patients who are scheduled for spine surgery and need positional change from supine to prone positioin.

You may qualify if:

  • Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia

You may not qualify if:

  • arrythmia
  • pulmonary disease
  • increased intracranial pressure
  • decreased cardiac function (ejection fraction \< 50%)
  • obesity (body mass index \> 40)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 20, 2021

Study Start

December 15, 2021

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations