Clinical trial NCT05565911: Postoperative Morbidity / Mortality Rates of Patients With Pulmonary Hypertension
Official title: The Relationship of Postoperative Morbidity / Mortality Rates of Patients With Pulmonary Hypertension With Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: oPAP Should be > 25mmHg in Right Heart Catheterization at Rest
There Should be Patients Who Will Undergo Non-cardiac and Non-obstetric Surgery
Keywords: pulmonary hypertension
hemodinamic monitorization
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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

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

Detailed description: Our study will be carried out by recording the patients with PHT who underwent non-cardiac and non-obstetric surgeries at Başkent University Ankara Hospital between 11/10/2021 and 11/10/2023. It was planned to select the patients participating in our study on a voluntary basis and to include only the patients who agreed to participate in the study. Informed consent will be obtained by informing the patients before the application.

Both patient groups will be evaluated in the anesthesia polyclinic in the preoperative period. Routine blood tests will be done. It was planned as a cohort study. Depending on the surgery type of the patients, GA or RA will be applied as appropriate. The drugs in the standard anesthesia method will be administered to the patients. Standard monitoring and, if necessary, other invasive monitoring methods will be applied. Echocardiography evaluations, pulmonary function tests will be planned, and control evaluations will be requested at the 3rd, 6th and 1st postoperative months.

By the team in the postoperative recovery unit, hypoventilation (falling below breath per minute), apnea (episodes longer than 10 seconds), hypoxemia (SpO2\<90, nasal O2 or Room Air), tachypnea, dyspnea, arrhythmia, chest pain, tachycardia, hypotension 30 minutes in terms of symptoms such as hypertension, laryngospasm, bronchospasm, subcostal retraction. They will be followed throughout. They will be evaluated in terms of analgesia control with Numeric Pain Score.

It will be evaluated in terms of postoperative pulmonary complications (tracheal reintubation) in the recovery unit and afterwards, extubation failure, pulmonary edema, and pneumothorax at the end of the case, and records will be kept.

Eligibility criteria: Inclusion Criteria:

* • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB\> 25mmHg olan hastalar,

  * Non-obstetrik ve non-kardiyak cerrahi geçirecek hastalar

Exclusion Criteria:

* • Dinlenme halinde sağ kalp kateterizasyonu ile oPAB\< 25mmHg olan hastalar,

  * Obstetrik veya kardiyak cerrahi geçirecek hastalar

Primary outcomes:
measure: Comparison of postoperative morbidity/mortality
timeFrame: 11/2021- 11/2023
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
References: