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

NCT04895527 | Completed

• 1 other identifier: Airtest-Negrín
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

airtest; atelectasis; postoperative period; complications

Outcome Measures

Primary Outcomes (2)

• Postoperative pulmonary complications

  to demonstrate the veracity of the air-test in the prevention of pulmonary complications in patients undergoing scheduled laparoscopic surgery

  30 days postoperatively

• Postoperative systemic complications

  to demonstrate the veracity of the air-test in the prevention of systemic complications in patients undergoing scheduled laparoscopic surgery

  30 days postoperatively

Secondary Outcomes (2)

• Incidence of positive air-test

  4 hours postoperatively

• Recruitment maneuvers and air-test

  from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients undergoing scheduled laparoscopic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

MeSH Terms

Conditions

Postoperative Complications; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ángel Ángel, MD

  Hospital Universitario de Gran Canaria Doctor Negrín

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

ES (1)