NCT06404892

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

1.4 years

First QC Date

May 5, 2024

Last Update Submit

May 3, 2025

Conditions

Keywords

postoperative pumonary complicationsARISCAT scoreLAS VEGAS scoreASA score

Outcome Measures

Primary Outcomes (1)

  • Postoperative pulmonary complications

    Incidence of composite pulmonary complications after surgery

    up to 30 days after surgery

Study Arms (1)

Group 1

Patients undergoing thoracic surgery and single-lung ventilation.

Procedure: Single-lung ventilation

Interventions

Patients undergoing thoracic surgery and intraoperative single-lung ventilation.

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing any thoracic procedure associated with intraoperative use of single-lung ventilation.

You may qualify if:

  • Adult patients undergoing any thoracic procedure associated with intraoperative single-lung ventilation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Andre P Schmidt, MD

    Hospital Nossa Senhora da Conceição

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre P Schmidt, MD

CONTACT

Rejane Piantamar

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

May 5, 2024

First Posted

May 8, 2024

Study Start

July 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations