NCT05851807

Intraoperative Lung Mechanics and Functional Evaluation in Post COVID-19 Thoracotomy Patients

Status unknown Last updated 23 May 2023

What this trial tests

trial in COVID-19 Pandemic in 120 participants. Status unknown.

Timeline

12 May 2022

Primary endpoint
12 May 2024

12 May 2024

Quick facts

Lead sponsor	Ankara University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	120
Start date	12 May 2022
Primary completion	12 May 2024
Estimated completion	12 May 2024
Sites	1 location across Turkey (Türkiye)

Conditions studied

• COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
• Anesthesia — all drugs for Anesthesia →
• Thoracic Diseases — all drugs for Thoracic Diseases →

Sponsor

Ankara University

Who can join

18 and older, any sex, with COVID-19 Pandemic or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

At the end of 2019, cases of an unknown respiratory infection were reported in the city of Wuhan in China. It was determined that the cause of this infection was a new virus belonging to the coronavirus family, which was named SARS-CoV-2. After the virus spread worldwide, the World Health Organization (WHO) declared it a pandemic. The clinical picture and disease caused by the virus were named COVID-19 (1). According to the WHO's data on 29.01.2022, the number of cases worldwide has exceeded 365 million, and the number of deaths has exceeded 5 million (2). Fever, cough, fatigue, shortness of breath, myalgia, sore throat, and headache are the main symptoms of COVID-19. Less frequently, it can cause nausea, vomiting, and diarrhea. The disease has a broad spectrum ranging from mild illness to severe illness that can result in death (3). In a study analyzing the data of approximately 72,000 patients in China, it was reported that 81% of the patients had no lung involvement or minimal involvement, 14% had severe involvement, and 5% had respiratory failure, shock, or multiple organ failure (4).

Attention is drawn to the long-term complications of COVID-19, such as myocarditis, heart failure, arrhythmia, dyspnea, oxygen dependence, impaired respiratory function tests, increased venous/arterial thromboembolism, decreased fitness, muscle and joint pain, increased anxiety-depression, post-traumatic stress disorder, and renal damage (5). It has been emphasized that patients who have recovered from COVID-19, especially older individuals and those with severe illness, are at risk of sarcopenia (7). It has been suggested that in patients who have recovered from COVID-19, direct viral damage, decreased physical activity level, and malnutrition result in decreased fitness and sarcopenia, which could be associated with increased morbidity in cancer surgeries (8).

It is reported that postoperative complications and deaths are higher in active COVID-19 patients than in those who do not have active disease (9). In a multicenter study, it was stated that postoperative pulmonary complications were observed in half of the patients who had COVID-19 during the perioperative period, and this condition was associated with high mortality. Most of these patients are those who need emergency surgical interventions (10).

According to studies in the literature, COVID-19 has multi-systemic effects, and some of these effects continue in the long term. It has been shown that the perioperative period with COVID-19 positivity is associated with higher pulmonary complications and mortality. It has been suggested that having had COVID-19 in the past may lead to worse postoperative outcomes. The studies in the literature were mostly conducted on patients who had surgery during the perioperative period while having COVID-19. Most of the patients required emergency surgical interventions. The effect of the patients' functional level on postoperative outcomes has not been examined. Our study focuses on the intraoperative and postoperative period of thoracic surgery patients who underwent surgery in the long term after COVID-19.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.