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NCT04895527
Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery
trial in Postoperative Complications in 250 participants. Completed in 30 June 2024.
30 June 2024
Quick facts
| Lead sponsor | Dr. Negrin University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 1 June 2021 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Spain |
Conditions studied
- Postoperative Complications — all drugs for Postoperative Complications →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04895527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dr. Negrin University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04895527 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Negrin University Hospital
- Last refreshed: 24 July 2024
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