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

NCT04895527 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-07-24

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Complications

Sponsors & Collaborators

  • Dr. Negrin University Hospital

    lead OTHER

Principal Investigators

  • Ángel Ángel, MD · Hospital Universitario de Gran Canaria Doctor Negrín

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895527 on ClinicalTrials.gov