Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period

Postoperative Pulmonary Atelectases Clinical Trial

Official title:

Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02121275
• Other study ID #: LUS
• Status: Active, not recruiting
• Start date: September 6, 2012
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Atelectases (collapsed lung areas) of 15-20% of total lung occur in up to 90% of patients who are anaesthetized and intubated. The goal of the present prospective study is to detect atelectatic areas in the perioperative period in the lungs of patients undergoing elective laparoscopic surgery non-invasively and without x-ray exposure. Results of lung ultrasound (LUS) as the experimental method will be compared to the results of Electrical Impedance Tomography (EIT) as the reference technique for the detection of atelectasis. A device for peripheral Oxygen saturation measurement (MASIMO Radical-8) will detect changes in ventilation. The investigators want to confirm or disprove former findings of the appearance of intraoperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 2023
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female,

• age 18 - 75

• BMI < 30

• Laparoscopic operation

Exclusion Criteria:

• Pregnancy

• Pulmonary infection

• Chronic pulmonary diseases

• Morbid Obesity

Related Conditions & MeSH terms

• Postoperative Pulmonary Atelectases
• Pulmonary Atelectasis

Intervention

Device:
• Ultrasound of the lungs
Ultrasound examination of the lungs
• Electric impedance tomography
Electric impedance tomography (EIT) is a noninvasive tool based on the measurement of electrical impedance changes within the thorax and lung tissue during ventilation and depicts the regional changes in ventilation in real time. To use electric impedance tomography 16 electrodes are applied in a circular fashion around the patient's chest, typically at the level of the 7th intercostal space.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography	Measurements, requiring 5 minutes each, are performed before induction of anaesthesia, after intubation, immediately before extubation and immediately after extubation. Outcome measure: comparison of how often atelectases are detected by lung ultrasound (experimental method) versus by electric impedance tomography (standard method)	on the day of laparoscopic surgery, expected average 2 hours in total
Secondary	respiratory variability of oxygen saturation	from induction of anaesthesia until extubation	on the day of laparoscopic surgery, expected average 2 hours in total