COVID-19 PandemicNCT05851807
Intraoperative Lung Mechanics and Functional Evaluation in Post COVID-19 Thoracotomy Patients
An observational study of COVID-19 Pandemic and Anesthesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic, Anesthesia, Thoracic Diseases
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2022to 12 May 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There has not been a similar study before, and in this respect, the study is a pilot study. Considering the number of patients who underwent lung resection and required evaluation with CPET in the Department of Thoracic Surgery of Ankara University Faculty of Medicine, the average annual number of operations is 250, and the number of patients for 3 years is predicted to be 750 in total. Considering the inclusion and exclusion criteria of the study, the number of patients was determined as 60 patients in the COVID-19 group and 60 patients in the control group.
Who may be able to join
- The Informed Consent Form must be signed by the patient
- Being over 18 years old
- The plan is to undergo pneumonectomy, lobectomy, segmentectomy, or various degrees of lung resection surgery
Who cannot join
- Informed Voluntary Consent Form not signed by the patient
- The presence of contraindications for the administration of cardiopulmonary exercise testing
- Lack of mental and psychological competence to complete the assessment and testing phases The presence of musculoskeletal problems that could hinder the implementation of evaluation and testing stages
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine
Ankara
CIGDEM YILDIRIM GUCLU, Associated Professor, +90 (532) 457 66 48, drcigdemyldrm@yahoo.com.tr
CIGDEM YILDIRIM GUCLU
About this study
Official title: Intraoperative Lung Mechanics, Postoperative Complications, and Functional Evaluation in Post COVID-19 Patients Undergoing Thoracic Surgery
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).
Read more
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.
Read the detailed description
Patients over the age of 18, who are planned to undergo thoracotomy, will be recruited. Those volunteers whose COVID-19 infection is confirmed by PCR test will form the COVID-19 patient group, while others will form the control group who did not have COVID-19. The patient group to be operated on and followed by the Department of Thoracic Surgery of the Ankara University, Faculty of Medicine will be analyzed.
Before starting the evaluations, the patients will be asked to review the informed consent form and give their consent to participate in the research. The sociodemographic data (name, surname, file number, date of birth, height, weight, marital status, education level, occupation, contact number) and medical history (systemic diseases and their duration, drugs used continuously and their duration) of the patients who agree to participate in the study will be recorded.
The ASA (American Society of Anesthesiologists) score will be determined in the preoperative period. Hemoglobin values before the operation will be recorded. It will be queried whether the participants had COVID-19, and in the group that had it, the date of COVID-19 infection, whether oxygen therapy was received before COVID-19, inhaler and BPAP-CPAP usage status, the presence of COPD, severe emphysema, uncontrolled asthma, OSAS (Obstructive sleep apnea syndrome), or previous pulmonary surgery history will be recorded. It will be queried whether imaging was performed with computed tomography during COVID-19 diagnosis and follow-up, and if performed, whether there was lung involvement and its percentage will be recorded. Medical treatments received by the patient during COVID-19, need for ventilation support will be noted. The duration of hospitalization in the inpatient and intensive care units due to COVID-19 will be recorded. The need for oxygen support after discharge due to COVID-19 will be queried. ARISCAT scores will be determined in both groups. Arterial blood gas results taken before the operation will be recorded. Predicted postoperative forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and DLCO (diffusing capacity of the lung for carbon monoxide) values will be determined before the operation.
Jamar dynamometer will be used to measure grip strength (Mathiowetz 1984). Assessment with Jamar dynamometer will be performed during the preoperative assessment, discharge phase, and 1-month control after the operation. Patients will be asked to squeeze the dynamometer as hard as they can while their upper extremities are positioned appropriately. Measurements will be taken three times for each side.
To evaluate lower extremity muscle strength and balance, a 5-repetition sit-to-stand test will be applied (Munoz-Bermejo 2021). This test will be performed during the preoperative assessment, discharge phase, and 1-month control after the operation. Patients will be asked to stand up from the chair five times while sitting on the chair. The time required for each patient to complete the test will be recorded.
- Conditions
- COVID-19 Pandemic, Anesthesia, Thoracic Diseases
- Keywords
- Covid-19, Thoracic Anesthesia
- Medical subject headings
- COVID-19, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patints with COVID-19 History | Patients with infected with COVID-19 in any time. | |
| Patints without COVID-19 History | Patients without COVID-19 history. |
What is being measured
The primary outcome is the main question the study is designed to answer.
significant difference in cardiopulmonary exercise capacity during and after thoracic surgery
There is a significant difference in cardiopulmonary exercise capacity during and after thoracic surgery between patients who have had COVID-19 and those who have not.
Measured: 1 month
Secondary outcomes (1)
significant difference in muscle strenght
There is a significant decrease in the 6-minute walking distance and grip strength after thoracic surgery in patients who have had COVID-19 compared to those who have not. Additionally, there is a significant increase in the duration of the 5-repetition sit-to-stand test.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start12 May 2022
- Primary completion12 May 2024 (estimated)
- Study completion12 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851807
- Sponsor's protocol ID
- i04-208-22
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atzrodt CL, Maknojia I, McCarthy RDP, Oldfield TM, Po J, Ta KTL, Stepp HE, Clements TP. A Guide to COVID-19: a global pandemic caused by the novel coronavirus SARS-CoV-2. FEBS J. 2020 Sep;287(17):3633-3650. doi: 10.1111/febs.15375. Epub 2020 Jun 16.
PubMed 32446285Chams N, Chams S, Badran R, Shams A, Araji A, Raad M, Mukhopadhyay S, Stroberg E, Duval EJ, Barton LM, Hajj Hussein I. COVID-19: A Multidisciplinary Review. Front Public Health. 2020 Jul 29;8:383. doi: 10.3389/fpubh.2020.00383. eCollection 2020.
PubMed 32850602Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Desai AD, Lavelle M, Boursiquot BC, Wan EY. Long-term complications of COVID-19. Am J Physiol Cell Physiol. 2022 Jan 1;322(1):C1-C11. doi: 10.1152/ajpcell.00375.2021. Epub 2021 Nov 24.
PubMed 34817268Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
PubMed 33428867Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. Aging Dis. 2020 Dec 1;11(6):1345-1351. doi: 10.14336/AD.2020.1014. eCollection 2020 Dec.
PubMed 33269092Casey P, Ang Y, Sultan J. COVID-19-induced sarcopenia and physical deconditioning may require reassessment of surgical risk for patients with cancer. World J Surg Oncol. 2021 Jan 11;19(1):8. doi: 10.1186/s12957-020-02117-x.
PubMed 33430881Doglietto F, Vezzoli M, Gheza F, Lussardi GL, Domenicucci M, Vecchiarelli L, Zanin L, Saraceno G, Signorini L, Panciani PP, Castelli F, Maroldi R, Rasulo FA, Benvenuti MR, Portolani N, Bonardelli S, Milano G, Casiraghi A, Calza S, Fontanella MM. Factors Associated With Surgical Mortality and Complications Among Patients With and Without Coronavirus Disease 2019 (COVID-19) in Italy. JAMA Surg. 2020 Aug 1;155(8):691-702. doi: 10.1001/jamasurg.2020.2713.
PubMed 32530453COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29.
PubMed 32479829Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
PubMed 6715829Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.
PubMed 34207604Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
PubMed 31689414Lollgen H, Leyk D. Exercise Testing in Sports Medicine. Dtsch Arztebl Int. 2018 Jun 15;115(24):409-416. doi: 10.3238/arztebl.2018.0409.
PubMed 29968559
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Lung Mechanics, Postoperative Complications, and Functional Evaluation in Post COVID-19 Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT05851807
- Acronym / sponsor ID
- i04-208-22
- Conditions
- COVID-19 Pandemic, Anesthesia, Thoracic Diseases
- Keywords
- Covid-19, Thoracic Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 12 May 2024 (estimated)
- Study completion
- 12 May 2024 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients over the age of 18, who are planned to undergo thoracotomy, will be recruited. Those volunteers whose COVID-19 infection is confirmed by PCR test will form the COVID-19 patient group, while others will form the control group who did not have COVID-19. The patient group to be operated on and followed by the Department of Thoracic Surgery of the Ankara University, Faculty of Medicine will be analyzed.
Before starting the evaluations, the patients will be asked to review the informed consent form and give their consent to participate in the research. The sociodemographic data (name, surname, file number, date of birth, height, weight, marital status, education level, occupation, contact number) and medical history (systemic diseases and their duration, drugs used continuously and their duration) of the patients who agree to participate in the study will be recorded.
The ASA (American Society of Anesthesiologists) score will be determined in the preoperative period. Hemoglobin values before the operation will be recorded. It will be queried whether the participants had COVID-19, and in the group that had it, the date of COVID-19 infection, whether oxygen therapy was received before COVID-19, inhaler and BPAP-CPAP usage status, the presence of COPD, severe emphysema, uncontrolled asthma, OSAS (Obstructive sleep apnea syndrome), or previous pulmonary surgery history will be recorded. It will be queried whether imaging was performed with computed tomography during COVID-19 diagnosis and follow-up, and if performed, whether there was lung involvement and its percentage will be recorded. Medical treatments received by the patient during COVID-19, need for ventilation support will be noted. The duration of hospitalization in the inpatient and intensive care units due to COVID-19 will be recorded. The need for oxygen support after discharge due to COVID-19 will be queried. ARISCAT scores will be determined in both groups. Arterial blood gas results taken before the operation will be recorded. Predicted postoperative forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and DLCO (diffusing capacity of the lung for carbon monoxide) values will be determined before the operation.
Jamar dynamometer will be used to measure grip strength (Mathiowetz 1984). Assessment with Jamar dynamometer will be performed during the preoperative assessment, discharge phase, and 1-month control after the operation. Patients will be asked to squeeze the dynamometer as hard as they can while their upper extremities are positioned appropriately. Measurements will be taken three times for each side.
To evaluate lower extremity muscle strength and balance, a 5-repetition sit-to-stand test will be applied (Munoz-Bermejo 2021). This test will be performed during the preoperative assessment, discharge phase, and 1-month control after the operation. Patients will be asked to stand up from the chair five times while sitting on the chair. The time required for each patient to complete the test will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patints with COVID-19 History | – | –Patients with infected with COVID-19 in any time. |
| Patints without COVID-19 History | – | –Patients without COVID-19 history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There has not been a similar study before, and in this respect, the study is a pilot study. Considering the number of patients who underwent lung resection and required evaluation with CPET in the Department of Thoracic Surgery of Ankara University Faculty of Medicine, the average annual number of operations is 250, and the number of patients for 3 years is predicted to be 750 in total. Considering the inclusion and exclusion criteria of the study, the number of patients was determined as 60 patients in the COVID-19 group and 60 patients in the control group.
Key inclusion criteria (3 listed)
- The Informed Consent Form must be signed by the patient
- Being over 18 years old
- The plan is to undergo pneumonectomy, lobectomy, segmentectomy, or various degrees of lung resection surgery
Key exclusion criteria (3 listed)
- Informed Voluntary Consent Form not signed by the patient
- The presence of contraindications for the administration of cardiopulmonary exercise testing
- Lack of mental and psychological competence to complete the assessment and testing phases The presence of musculoskeletal problems that could hinder the implementation of evaluation and testing stages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
significant difference in cardiopulmonary exercise capacity during and after thoracic surgery
Time frame: 1 month
There is a significant difference in cardiopulmonary exercise capacity during and after thoracic surgery between patients who have had COVID-19 and those who have not.
1 secondary outcome
significant difference in muscle strenght
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 32446285Atzrodt CL, Maknojia I, McCarthy RDP, Oldfield TM, Po J, Ta KTL, Stepp HE, Clements TP. A Guide to COVID-19: a global pandemic caused by the novel coronavirus SARS-CoV-2. FEBS J. 2020 Sep;287(17):3633-3650. doi: 10.1111/febs.15375. Epub 2020 Jun 16.
- Background: PubMed 32850602Chams N, Chams S, Badran R, Shams A, Araji A, Raad M, Mukhopadhyay S, Stroberg E, Duval EJ, Barton LM, Hajj Hussein I. COVID-19: A Multidisciplinary Review. Front Public Health. 2020 Jul 29;8:383. doi: 10.3389/fpubh.2020.00383. eCollection 2020.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 34817268Desai AD, Lavelle M, Boursiquot BC, Wan EY. Long-term complications of COVID-19. Am J Physiol Cell Physiol. 2022 Jan 1;322(1):C1-C11. doi: 10.1152/ajpcell.00375.2021. Epub 2021 Nov 24.
- Background: PubMed 33428867Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.
- Background: PubMed 33269092Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. Aging Dis. 2020 Dec 1;11(6):1345-1351. doi: 10.14336/AD.2020.1014. eCollection 2020 Dec.
- Background: PubMed 33430881Casey P, Ang Y, Sultan J. COVID-19-induced sarcopenia and physical deconditioning may require reassessment of surgical risk for patients with cancer. World J Surg Oncol. 2021 Jan 11;19(1):8. doi: 10.1186/s12957-020-02117-x.
- Background: PubMed 32530453Doglietto F, Vezzoli M, Gheza F, Lussardi GL, Domenicucci M, Vecchiarelli L, Zanin L, Saraceno G, Signorini L, Panciani PP, Castelli F, Maroldi R, Rasulo FA, Benvenuti MR, Portolani N, Bonardelli S, Milano G, Casiraghi A, Calza S, Fontanella MM. Factors Associated With Surgical Mortality and Complications Among Patients With and Without Coronavirus Disease 2019 (COVID-19) in Italy. JAMA Surg. 2020 Aug 1;155(8):691-702. doi: 10.1001/jamasurg.2020.2713.
- Background: PubMed 32479829COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29.
- Background: PubMed 6715829Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.
- Background: PubMed 34207604Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.
- Background: PubMed 31689414Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COVID-19 Pandemic
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
Active, not recruitingPhase 2
Improving Mental Health Among the LGBTQ+ Community
Anxiety, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankara University Faculty of Medicine
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Anesthesia, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant difference in cardiopulmonary exercise capacity during and after thoracic surgery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851807, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.