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

Sponsor
Medical University of Vienna (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02121275
Collaborator
(none)
44
Enrollment
1
Location
125
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound of the lungs
  • Device: Electric impedance tomography

Study Design

Study Type:
Observational
Anticipated Enrollment :
44 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Lung Ultrasound for the Detection of Pulmonary Atelectasis in the Perioperative Period
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
Ultrasound examination of the lungs
Other Names:
  • Sonosite ultrasound device (M-Turbo)

    • Device: 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.
    Other Names:
  • EIT (Pulmovista, Draeger)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography [on the day of laparoscopic surgery, expected average 2 hours in total]

      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)

    Secondary Outcome Measures

    1. respiratory variability of oxygen saturation [on the day of laparoscopic surgery, expected average 2 hours in total]

      from induction of anaesthesia until extubation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female,

    • age 18 - 75

    • BMI < 30

    • Laparoscopic operation

    Exclusion Criteria:

    • Pregnancy

    • Pulmonary infection

    • Chronic pulmonary diseases

    • Morbid Obesity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care Vienna Austria A-1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Roman Ullrich, MD, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Roman Ullrich, MD, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT02121275
    Other Study ID Numbers:
    • LUS
    First Posted:
    Apr 23, 2014
    Last Update Posted:
    Dec 28, 2021
    Last Verified:
    Dec 1, 2021
    Additional relevant MeSH terms:
    Pulmonary Atelectasis

    Study Results

    No Results Posted as of Dec 28, 2021