NCT05565911

Brief Summary

Pulmonary hypertension (PHT) is an oPAP ≥25 mmHg as assessed by right heart catheterization at rest. It is divided into 5 groups according to its etiology and mechanism. The first group is patients with pulmonary arterial hypertension due to various reasons (drugs, connective tissue diseases, etc.). Group 2 is classified as left heart failure, group 3 is due to chronic lung disease and hypoxemia, group 4 is due to pulmonary arterial obstruction (most commonly CTEPH), and group 5 is patients with pulmonary hypertension due to multifactorial unspecified causes. In the pathophysiology, pulmonary hypertension occurs when the balance is disturbed by endothelial dysfunction, decrease in vasodilator mediators (NO, prostacyclin) and increase in vasoconstrictor mediators (endothelin-1, serotonin, thromboxan) in the vascular bed. Perioperatively, patients with WHO functional classification \>2, right ventricular hypertrophy, obese, chronic renal failure, previous PTE, COPD, diabetes mellitus are more prone to complications related to pulmonary hypertension. Although factors such as emergency surgery, intraoperative vasopressor use, delayed intubation, acidosis, and hyperthermia pave the way for postoperative pulmonary complications, attention should be paid to mortality and morbidity since they are also preventable factors. Postoperatively, as a result of the supine position triggering bronchospasm with secretions, acute lung injury in addition to the existing comorbidity occurs. With the increase in respiratory workload, acute respiratory failure develops with symptoms such as hypoxemia and hypercarbia. Residual anesthesia, increased pain or prolonged mechanical ventilation time also decrease functional residual capacity, increasing the possibility of atelectasis development. With the records we kept in our study, we aimed to show which complications the patients with pulmonary hypertension faced after their surgeries due to their underlying diseases and References ESC/ERC Guidelines Eurepean Heart Journal 2016; 37:67-119 Aguirre MA, et al. Advances in Anesthesia 2018;36: 201-30

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

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

October 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 30, 2022

Last Update Submit

September 30, 2022

Conditions

Keywords

pulmonary hypertensionhemodinamic monitorization

Outcome Measures

Primary Outcomes (1)

  • Comparison of postoperative morbidity/mortality

    In this study, we investigated how the risk factors of patients with pulmonary hypertension can be evaluated and how the treatment plan can be arranged to prevent postoperative complications and reduce postoperative morbidity/mortality rates. We aim to compare the postoperative morbidity/mortality rates and complication frequency of patients who were evaluated and treated preoperatively with those who did not receive treatment.

    11/2021- 11/2023

Interventions

this is an observational study, there is no intervention.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Araştırma kapsamında pulmoner hipertansiyonu olan hastaların geçirecekleri cerrahilerde kendi hasta popülasyonlarına özel ne gibi risk faktörlerine sahip oldukları, tedavi olan ve olmayanlarda postoperatif komplikasyon gelişme sıklığının araştırılması planlanmaktadır

You may qualify if:

  • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB\> 25mmHg olan hastalar,
  • Non-obstetrik ve non-kardiyak cerrahi geçirecek hastalar

You may not qualify if:

  • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB\< 25mmHg olan hastalar,
  • Obstetrik veya kardiyak cerrahi geçirecek hastalar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Begüm Nemika Gökdemir, MD

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 4, 2022

Record last verified: 2022-09

Locations