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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Aurelio Rodríguez Pérez, PhD; Phone Number: 928450969; Email: arodperp@gobiernodecanarias.org
• Study Contact Backup: Name: Ángel Becerra, MD; Phone Number: +34676229025; Email: angbecbol@gmail.com

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Recruiting
      • Ángel Becerra
      • Contact: Ángel Becerra, MD; Phone Number: +34676229025
      • Contact: Email: angbecbol@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of positive air-test	to detect the prevalence of patients showing positive in the air-test in the postoperative period after scheduled laparoscopic surgery	4 hours postoperatively
Recruitment maneuvers and air-test	to demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test	from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively

Collaborators and Investigators

• Sponsor: Dr. Negrin University Hospital
• Investigators: Principal Investigator: Ángel Ángel, MD, Hospital Universitario de Gran Canaria Doctor Negrin

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: atelectasis; complications; airtest; postoperative period
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Airtest-Negrín

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data can be available after request to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No