Postoperative ComplicationsNCT06404892
ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Thoracic Surgery
An observational study of Postoperative Complications, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Single-lung ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients undergoing any thoracic procedure associated with intraoperative use of single-lung ventilation.
Who may be able to join
- Adult patients undergoing any thoracic procedure associated with intraoperative single-lung ventilation.
Who cannot join
- Patients undergoing cardiac surgery, pregnant women, patient refusal, contraindications to proposed surgical, anesthetic or analgesic techniques, sepsis, psychiatric illness, uncontrolled endocrine, kidney or liver disease and coagulopathies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
HCPA
Porto Alegre, Rio Grande do Sul, 90035903
Andre P Schmidt, MD, PhD, 5551996412212, apschmidt@hcpa.edu.br
About this study
Official title: ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery With Single-lung Ventilation
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance. Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective on the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. This is a prospective observational study in order to evaluate the performance of the ASA, ARISCAT and LAS VEGAS risk scores for predict the occurrence of postoperative pulmonary complications (PPC) in patients undergoing thoracic surgery with single-lung ventilation.
Read the detailed description
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure; CPP prolong hospital stay and increase costs in health systems. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance.
Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective in the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. In this study, we will prospectively evaluate the performance of ASA, ARISCAT and LAS VEGAS scores in predicting patients who present with CPP in thoracic surgeries using single-lung ventilation. We will also analyze other potential patient risk factors as well as complications presented.
This is a prospective observational study. Data will be collected using a standardized form at the surgical center of Hospital Nossa Senhora da Conceição and at the Hospital de Clínicas de Porto Alegre, evaluated preoperatively, intraoperatively and postoperatively. Direct observation and recording of variables studied by the anesthesiology medical team of both hospitals, previously trained and supervised by the main researcher. Patients will be monitored until hospital discharge or up to a maximum period of 30 days of hospital admission.
- Conditions
- Postoperative Complications
- Being tested
- Single-lung ventilation
- Keywords
- postoperative pumonary complications, ARISCAT score, LAS VEGAS score, ASA score
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-lung ventilationProcedure or surgery
Patients undergoing thoracic surgery and intraoperative single-lung ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients undergoing thoracic surgery and single-lung ventilation. Receives: Procedure: Single-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Incidence of composite pulmonary complications after surgery
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Prato Schmidt, Hospital Nossa Senhora da Conceicao
- Investigators
- Andre P Schmidt, MD, Principal investigator, Hospital Nossa Senhora da Conceição
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404892
- Sponsor's protocol ID
- 75871723.4.0000.5530
- Status last verified
- May 2025
- First submitted
- 5 May 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARISCAT, ASA and LAS VEGAS Risk Scores and the Incidence of Postoperative Pulmonary Complications in Patients Undergoing Thoracic Surgery With Single-lung Ventilation
- ClinicalTrials.gov ID
- NCT06404892
- Acronym / sponsor ID
- 75871723.4.0000.5530
- Conditions
- Postoperative Complications
- Keywords
- postoperative pumonary complications, ARISCAT score, LAS VEGAS score, ASA score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 May 2024 (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.
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance. Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective on the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. This is a prospective observational study in order to evaluate the performance of the ASA, ARISCAT and LAS VEGAS risk scores for predict the occurrence of postoperative pulmonary complications (PPC) in patients undergoing thoracic surgery with single-lung ventilation.
Detailed description
Postoperative pulmonary complications (PPC) are among the main complications after the anesthetic-surgical procedure; CPP prolong hospital stay and increase costs in health systems. It can be said that thoracic surgery results in impaired respiratory function in the postoperatively, due to the decrease in lung volumes and capacities (the vital capacity decreases by approximately 50-60% and functional residual capacity decreases by approximately 30% in the first 24 hours after surgery) diaphragm dysfunction, gas exchange impaired, cough and ineffective mucociliary clearance.
Thus, our hypothesis is that the application of preoperative risk scores normally used for non-cardiac and non-thoracic surgeries may be effective in the predictability of the occurrence of CPP in patients undergoing ventilation single-lung. In this study, we will prospectively evaluate the performance of ASA, ARISCAT and LAS VEGAS scores in predicting patients who present with CPP in thoracic surgeries using single-lung ventilation. We will also analyze other potential patient risk factors as well as complications presented.
This is a prospective observational study. Data will be collected using a standardized form at the surgical center of Hospital Nossa Senhora da Conceição and at the Hospital de Clínicas de Porto Alegre, evaluated preoperatively, intraoperatively and postoperatively. Direct observation and recording of variables studied by the anesthesiology medical team of both hospitals, previously trained and supervised by the main researcher. Patients will be monitored until hospital discharge or up to a maximum period of 30 days of hospital admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Single-lung ventilationPatients undergoing thoracic surgery and single-lung ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing any thoracic procedure associated with intraoperative use of single-lung ventilation.
Key inclusion criteria (1 listed)
- Adult patients undergoing any thoracic procedure associated with intraoperative single-lung ventilation.
Key exclusion criteria (1 listed)
- Patients undergoing cardiac surgery, pregnant women, patient refusal, contraindications to proposed surgical, anesthetic or analgesic techniques, sepsis, psychiatric illness, uncontrolled endocrine, kidney or liver disease and coagulopathies.
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 |
|---|---|---|
| Single-lung ventilationPatients undergoing thoracic surgery and intraoperative single-lung ventilation. | Procedure or surgery | Group 1 |
Primary outcome
Postoperative pulmonary complications
Time frame: up to 30 days after surgery
Incidence of composite pulmonary complications after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- 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.
Andre P Schmidt, MD principal investigator
Hospital Nossa Senhora da Conceição
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 Postoperative Complications, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
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: looking for participants now, as of the sponsor's last update on 6 May 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre P Schmidt, MD (5551996412212, aschmidt@ghc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.