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Completed

NCT Number: NCT04895527

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ángel Becerra

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative pulmonary complications

    Time frame: 30 days postoperatively

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

  2. Postoperative systemic complications

    Time frame: 30 days postoperatively

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

Secondary outcomes

  1. Incidence of positive air-test

    Time frame: 4 hours postoperatively

    to detect the prevalence of patients showing positive in the air-test in the postoperative period after scheduled laparoscopic surgery

  2. Recruitment maneuvers and air-test

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

    to demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 20, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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