COVID - 19NCT07118917
COVID-19 Infection and Thoracic Anesthesia?
An observational study of COVID - 19 and Thoracic Anesthesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
SARS-CoV-2 has infected more than 776 million people worldwide, raising concerns about its impact on patients with lung cancer, the most common cancer in men and the second most common cancer in women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID - 19, Thoracic Anesthesia, Mechanical Power
- What is being tested?
- Prehabilitation and No postponement
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2024to 5 Jun 2025
- 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: patients operated for thoracic surgery
Who may be able to join
- age ≥18 years and planned procedures, including pneumonectomy, lobectomy, segmentectomy, or other lung resections
Who cannot join
- patient refusal to participate and inability to provide informed consent due to psychological or mental incapacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Prior COVID-19 Infection Affect Lung Dynamics During Thoracic Anesthesia?
SARS-CoV-2 has infected more than 776 million people worldwide, raising concerns about its impact on patients with lung cancer, the most common cancer in men and the second most common cancer in women. Previous studies have suggested that COVID-19 may worsen lung dysfunction in patients undergoing surgery and that the coexistence of COVID-19 and lung cancer increases the risk of complications and mortality. It has been recommended that surgery be delayed after COVID-19 infection to reduce postoperative risk. This study examined the effects of prior COVID-19 infection on respiratory mechanics in patients undergoing thoracic surgery for lung cancer.
Read the detailed description
COVID-19 positivity was confirmed in 53 patients via SARS-CoV-2 RT-Prowhite, and the remaining 57 patients were classified as COVID-19 negative on the basis of a lack of prior positive PCR tests and the absence of COVID-19 symptoms in medical records. Statistical analysis was performed via SPSS Statistics for Windows, Version 17.0 (Chicago: SPSS Inc.). The Shapiro-Wilk test was used to assess the normality of the data distribution, a standard approach to determine the appropriateness of parametric versus nonparametric tests. For variables that did not follow a normal distribution, the Mann-Whitney U test was applied because of its suitability for comparing two independent groups with nonparametric data. For normally distributed variables, Student's t test was used to compare means between the COVID-19-positive and COVID-19-negative groups. Logistic regression was employed to evaluate the association between waiting time intervals (as a continuous predictor) and postoperative pulmonary complications (a binary outcome), given its robustness for such analyses. Categorical data, such as operation types and comorbidities, were compared via the chi-square test or Fisher's exact test when expected cell counts were low, ensuring statistical validity. A p value <0.05 was considered to indicate statistical significance. Compared with experimental models such as D'Albo et al.[21] (n = 82), which effectively identified significant effects of mechanical power, our sample size of 110 patients was adequate to detect differences in lung dynamics. Patients were monitored with a bispectral index (BIS) (Covidien, Boulder, CO, USA) and Train-of-Four (TOF) (GE HealthCare, Chicago, Illinois, USA) in addition to the monitoring recommended by the American Society of Anesthesiologist (ASA). Patients were given IV access with a 22G branch contralateral to the side to be operated on. After preoxygenation with 80% FiO2, anesthesia was induced with 1 mg/kg lidocaine and 1.5 mcg/kg fentanyl followed by propofol under BIS guidance, and 1.2 mg/kg rocuronium was administered after the reference value for TOF was taken. After TOF 0 was observed, patients were intubated with a double lumen tube with a Macintosh blade. The size of the tube was determined to be 35-37 Fr for women and 39-41 Fr for men. The placement of the tube was confirmed via bronchoscopy. Patients were placed in the lateral decubitus position after fixation. After the position was completed, the placement of the tube was confirmed again via bronchoscopy. The mechanical ventilator settings were determined to be 7 ml/kg according to the ideal weight for both lungs and 5 ml/kg for single-lung ventilation. The PEEP (positive end-expiration pressure) was set as 5 cm H2O for all of the patients. FiO2 was titrated to a SpO2 >92. Mechanical power (MP) was calculated via the simplified formula of Gattinoni et al.: MP = 0.098 × RR × VT × (Ppeak - Pplat/2), where RR is the respiratory rate, VT is the tidal volume, Ppeak is the peak pressure, and Pplat is the plateau pressure. This measures the energy delivered to the lungs during ventilation, expressed in joules/minute.
- Conditions
- COVID - 19, Thoracic Anesthesia, Mechanical Power
- Being tested
- Prehabilitation, No postponement
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Patients with COVID-19 history postponed for the surgery according to multidisciplinary decision.
No postponementOther
Patients who were COVID negative proceeded for surgery
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 positive | COVID-19 positive patients Receives: Other: Prehabilitation | |
| COVID-19 negative | COVID-19 negative Receives: Other: No postponement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Power Calculation
Measured: Intraoperative period ( Day of Surgery)
Secondary outcomes (1)
Plato Pressure
Measured: Intraoperative period ( Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start12 Sep 2024
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID - 19Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
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
- NCT07118917
- Sponsor's protocol ID
- 2024/667
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asiller OO, Guclu CY, Erkoc SK, Genc A, Balci BMK, Yenigun B, Kahya Y, Turan BK, Kurtais Y. Does a prior COVID-19 infection affect lung dynamics during thoracic anesthesia? BMC Anesthesiol. 2026 Feb 10;26(1):167. doi: 10.1186/s12871-026-03639-9.
PubMed 41663941
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Prior COVID-19 Infection Affect Lung Dynamics During Thoracic Anesthesia?
- ClinicalTrials.gov ID
- NCT07118917
- Acronym / sponsor ID
- 2024/667
- Conditions
- COVID - 19, Thoracic Anesthesia, Mechanical Power
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 12 Aug 2025 (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.
SARS-CoV-2 has infected more than 776 million people worldwide, raising concerns about its impact on patients with lung cancer, the most common cancer in men and the second most common cancer in women. Previous studies have suggested that COVID-19 may worsen lung dysfunction in patients undergoing surgery and that the coexistence of COVID-19 and lung cancer increases the risk of complications and mortality. It has been recommended that surgery be delayed after COVID-19 infection to reduce postoperative risk. This study examined the effects of prior COVID-19 infection on respiratory mechanics in patients undergoing thoracic surgery for lung cancer.
Detailed description
COVID-19 positivity was confirmed in 53 patients via SARS-CoV-2 RT-Prowhite, and the remaining 57 patients were classified as COVID-19 negative on the basis of a lack of prior positive PCR tests and the absence of COVID-19 symptoms in medical records. Statistical analysis was performed via SPSS Statistics for Windows, Version 17.0 (Chicago: SPSS Inc.). The Shapiro-Wilk test was used to assess the normality of the data distribution, a standard approach to determine the appropriateness of parametric versus nonparametric tests. For variables that did not follow a normal distribution, the Mann-Whitney U test was applied because of its suitability for comparing two independent groups with nonparametric data. For normally distributed variables, Student's t test was used to compare means between the COVID-19-positive and COVID-19-negative groups. Logistic regression was employed to evaluate the association between waiting time intervals (as a continuous predictor) and postoperative pulmonary complications (a binary outcome), given its robustness for such analyses. Categorical data, such as operation types and comorbidities, were compared via the chi-square test or Fisher's exact test when expected cell counts were low, ensuring statistical validity. A p value <0.05 was considered to indicate statistical significance. Compared with experimental models such as D'Albo et al.[21] (n = 82), which effectively identified significant effects of mechanical power, our sample size of 110 patients was adequate to detect differences in lung dynamics. Patients were monitored with a bispectral index (BIS) (Covidien, Boulder, CO, USA) and Train-of-Four (TOF) (GE HealthCare, Chicago, Illinois, USA) in addition to the monitoring recommended by the American Society of Anesthesiologist (ASA). Patients were given IV access with a 22G branch contralateral to the side to be operated on. After preoxygenation with 80% FiO2, anesthesia was induced with 1 mg/kg lidocaine and 1.5 mcg/kg fentanyl followed by propofol under BIS guidance, and 1.2 mg/kg rocuronium was administered after the reference value for TOF was taken. After TOF 0 was observed, patients were intubated with a double lumen tube with a Macintosh blade. The size of the tube was determined to be 35-37 Fr for women and 39-41 Fr for men. The placement of the tube was confirmed via bronchoscopy. Patients were placed in the lateral decubitus position after fixation. After the position was completed, the placement of the tube was confirmed again via bronchoscopy. The mechanical ventilator settings were determined to be 7 ml/kg according to the ideal weight for both lungs and 5 ml/kg for single-lung ventilation. The PEEP (positive end-expiration pressure) was set as 5 cm H2O for all of the patients. FiO2 was titrated to a SpO2 >92. Mechanical power (MP) was calculated via the simplified formula of Gattinoni et al.: MP = 0.098 × RR × VT × (Ppeak - Pplat/2), where RR is the respiratory rate, VT is the tidal volume, Ppeak is the peak pressure, and Pplat is the plateau pressure. This measures the energy delivered to the lungs during ventilation, expressed in joules/minute.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 positive | – | Other: PrehabilitationCOVID-19 positive patients |
| COVID-19 negative | – | Other: No postponementCOVID-19 negative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients operated for thoracic surgery
Key inclusion criteria (1 listed)
- age ≥18 years and planned procedures, including pneumonectomy, lobectomy, segmentectomy, or other lung resections
Key exclusion criteria (1 listed)
- patient refusal to participate and inability to provide informed consent due to psychological or mental incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationPatients with COVID-19 history postponed for the surgery according to multidisciplinary decision. | Other | COVID-19 positive |
| No postponementPatients who were COVID negative proceeded for surgery | Other | COVID-19 negative |
Primary outcome
Mechanical Power Calculation
Time frame: Intraoperative period ( Day of Surgery)
1 secondary outcome
Plato Pressure
Time frame: Intraoperative period ( Day of Surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 41663941Asiller OO, Guclu CY, Erkoc SK, Genc A, Balci BMK, Yenigun B, Kahya Y, Turan BK, Kurtais Y. Does a prior COVID-19 infection affect lung dynamics during thoracic anesthesia? BMC Anesthesiol. 2026 Feb 10;26(1):167. doi: 10.1186/s12871-026-03639-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Thoracic 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Power Calculation (time frame: Intraoperative period ( Day of Surgery)). 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 NCT07118917, which also lists 1 linked publication.
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 12 Aug 2025.