NCT06237543

Brief Summary

TAPSE, one of the methods for evaluating right ventricular systolic function; It is a bar parameter that can easily measure apex-basal shortening and provides specific information about global RV function. TAPSE/PASP can be calculated as load-independent parameters to evaluate RV function. Because RV function is sensitive to change in afterload, known as the RV-pulmonary circulation (PC) connection. This study aims to identify patients who are candidates for hypotensive events due to general anesthesia in a hemodynamically stable population.

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
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

January 15, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 15, 2024

Last Update Submit

January 31, 2024

Conditions

Keywords

TAPSEPASPHYPOTENSİONPULMONER RESECTİON

Outcome Measures

Primary Outcomes (1)

  • echocardiography

    TAPSE/ PASP (mm/mmHg)

    30 minute

Secondary Outcomes (1)

  • tension

    4-5 hours

Study Arms (2)

Hypotension

Patients with a 30% decrease in SBP from baseline and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered to have hypotension.

Other: hypotension

none hypotension

Patients who do not have a 30% decrease from the baseline in SBP and a decrease in MAP below 65 mmHg in the first 10 minutes after anesthesia induction will be considered as not having hypotension.

Interventions

MAP below 55 mmHg or long-term (2 minutes or more) hypotensive attacks will be treated with ephedrine 0.1mg/kg.

Also known as: treatment
Hypotension

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ASA1-3 patients aged 18-75 who will undergo pulmonary resection surgery

You may qualify if:

  • Written informed consent;
  • years old
  • ASA Physical Status 1-3;
  • Patients planned for pulmonary resection surgery

You may not qualify if:

  • The patient is pregnant
  • After cardiac surgery
  • Severe pulmonary hypertension
  • Severe valve disease
  • Hypertrophic or dilated cardiomyopathy
  • Presence of acute myocardial infarction
  • Patients with severe visual or hearing impairment/disability
  • ASA physical status IV or V
  • Ischemic heart disease, conduction disorder.
  • History of long-term use of certain medications (β-blockers, angiotensin converting enzyme inhibitors, analgesics, sedatives or tricyclic antidepressants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferdi Gülaştı

Aydin, 09020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Interventions

Hypotension, ControlledTherapeutics

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

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

Study Record Dates

First Submitted

January 15, 2024

First Posted

February 1, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2026

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations