Clinical trial NCT04895527: Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery
Official title: Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: airtest
atelectasis
postoperative period
complications
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing scheduled laparoscopic surgery will be included and informed consent will be asked to perform air-test postoperatively.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: 30 days postoperatively
measure: Postoperative systemic complications
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Incidence of positive air-test
timeFrame: 4 hours postoperatively
measure: Recruitment maneuvers and air-test
timeFrame: from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Ángel, MD
role: PRINCIPAL_INVESTIGATOR
References: