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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04895527
Enrollment
250
Registered
2021-05-20
Start date
2021-06-01
Completion date
2024-06-30
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

airtest, atelectasis, postoperative period, complications

Brief 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.

Detailed description

The persistence of postsurgical atelectasis is potentially associated with complications such as pneumonia, acute respiratory distress, and hypoxemia. This promotes other systemic complications such as myocardial ischemia or healing defects, negatively affecting morbidity, healthcare costs, and postoperative survival. Pre and intraoperative hemoglobin saturation levels are an independent risk factor for postoperative pulmonary complications. The airtest, based on the measurement of peripheral oxygen saturation (SpO2) with ambient air in the early postoperative period, is a useful tool in the prevention of moderate-severe pulmonary postsurgical complications. 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, parameters, 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 at the Doctor Negrín University Hospital of Gran Canaria. 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.

Interventions

None listed

Sponsors

Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing scheduled laparoscopic surgery

Exclusion criteria

* Pregnant or lactating women. * Presence of moderate to severe acute respiratory distress. * Patients suffering from heart failure. * Patients undergoing invasive mechanical ventilation during the 15 days prior to surgery. * Patients with a history of cardiothoracic surgery

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pulmonary complications30 days postoperativelyto demonstrate the veracity of the air-test in the prevention of pulmonary complications in patients undergoing scheduled laparoscopic surgery
Postoperative systemic complications30 days postoperativelyto demonstrate the veracity of the air-test in the prevention of systemic complications in patients undergoing scheduled laparoscopic surgery

Secondary

MeasureTime frameDescription
Incidence of positive air-test4 hours postoperativelyto detect the prevalence of patients showing positive in the air-test in the postoperative period after scheduled laparoscopic surgery
Recruitment maneuvers and air-testfrom the intraoperative period (recruitment maneuvers) until 4 hours postoperativelyto demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026