NCT04580030

Brief Summary

the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 9, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 2, 2020

Last Update Submit

October 18, 2020

Conditions

Keywords

General anesthesiatricuspid anular plane systolic excursionhypotension

Outcome Measures

Primary Outcomes (1)

  • tricuspid anular plane systolic excursion(TAPSE)

    The investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.

    TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.

Study Arms (2)

hypotension

Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure \<90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension".

no hypotension

Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure \<90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension".

Eligibility Criteria

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

It was planned that a total of 40 patients undergoing elective general surgery under general anesthesia with standard general anesthesia induction would be included in this prospective and observational study.

You may qualify if:

  • Patients scheduled for elective surgery
  • Patients who will receive general anesthesia
  • Patients between 18-65 years of age
  • Physical status I or II according to the American Society of Anesthetists (ASA) in preoperative evaluation
  • Those without known heart disease
  • Patients with TAPSE value above 1.6 cm

You may not qualify if:

  • Patients under the age of 8 and over 65,
  • Pregnant patients,
  • Patients who refuse to participate in the study,
  • ASA III and above,
  • Patients with known heart disease,
  • Patients with TAPSE value of less than 1.6 measured with Transthoracic Echocardiography will not be allowed to be included in the study.
  • Patients with difficult airway management or difficult intubation will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (3)

  • Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.

    PMID: 26771910BACKGROUND
  • Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.

  • Main AB, Braham R, Campbell D, Inglis AJ, McLean A, Orde S. Subcostal TAPSE: a retrospective analysis of a novel right ventricle function assessment method from the subcostal position in patients with sepsis. Ultrasound J. 2019 Aug 27;11(1):19. doi: 10.1186/s13089-019-0134-7.

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ferdi Gülaştı

    Bursa City Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Specialist of anesthesiology and reanimation

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

September 9, 2020

Primary Completion

September 9, 2021

Study Completion

September 10, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations