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

NCT02121275 | Unknown

• 1 other identifier: LUS
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pulmonary Atelectases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• respiratory variability of oxygen saturation

  on the day of laparoscopic surgery, expected average 2 hours in total

Study Arms (1)

Laparoscopic surgery

Patients undergoing laparoscopic surgery under general anaesthesia, patients undergo ultrasound of the lungs and electric impedance tomography at 4 times during anaesthesia

Device: Ultrasound of the lungs; Device: Electric impedance tomography

Interventions

Ultrasound of the lungs DEVICE

Ultrasound examination of the lungs

Also known as: Sonosite ultrasound device (M-Turbo)

Laparoscopic surgery

Electric impedance tomography DEVICE

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.

Also known as: EIT (Pulmovista, Draeger)

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective laparoscopic surgery at the Medical University of Vienna

You may qualify if:

• Male or female,
• age 18 - 75
• BMI \< 30
• Laparoscopic operation

You may not qualify if:

• Pregnancy
• Pulmonary infection
• Chronic pulmonary diseases
• Morbid Obesity

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roman Ullrich, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 23, 2014
• Study Start: September 6, 2012
• Primary Completion: June 30, 2016
• Study Completion: June 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

AU (1)