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NCT04895527

Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery

Completed Last updated 24 July 2024
What this trial tests

trial in Postoperative Complications in 250 participants. Completed in 30 June 2024.

Timeline
1 June 2021
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorDr. Negrin University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment250
Start date1 June 2021
Primary completion30 June 2024
Estimated completion30 June 2024
Sites1 location across Spain

Conditions studied

Sponsor

Dr. Negrin University Hospital

Who can join

18 and older, any sex, with Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis. A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery. Secondary objectives: * Measure the incidence of positive results in the air-test. * Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test * Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Postoperative Pulmonary Complications After Laparoscopic Surgery: Risk Factors and Predictive Scores.
    Valencia L, Becerra-Bolaños Á, Rodríguez-Sánchez R, Ojeda N, et al · · 2025 · cited 1× · PMID 41011025 · DOI 10.3390/medicina61091635

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Other recruiting trials for Postoperative Complications

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04895527.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing