Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04895527 |
| Other study ID # |
Airtest-Negrín |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Dr. Negrin University Hospital |
| Contact |
Ángel Becerra, MD |
| Phone |
+34676229025 |
| Email |
angbecbol[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
