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

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ClinicalTrials.gov Identifier: NCT02121275
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Roman Ullrich, Medical University of Vienna

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
Postoperative Pulmonary Atelectases Device: Ultrasound of the lungs Device: Electric impedance tomography

Study Type : Observational
Estimated 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 : January 2012
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: 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 Name: EIT (Pulmovista, Draeger)




Primary Outcome Measures :
  1. Correlation between evidence of atelectasis in lung ultrasound and evidence of atelectasis in electric impedance tomography [ Time Frame: 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 [ Time Frame: on the day of laparoscopic surgery, expected average 2 hours in total ]
    from induction of anaesthesia until extubation



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective laparoscopic surgery at the Medical University of Vienna
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121275


Contacts
Contact: Roman Ullrich, MD +43 1 40400 ext 41020 roman.ullrich@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Dept. of Anesthesiology and General Intensive Care Recruiting
Vienna, Austria, A-1090
Contact: Ullrich       roman.ullrich@meduniwien.ac.at   
Sub-Investigator: Katharina Krenn, MD         
Sub-Investigator: Oliver Panzer, MD         
Sub-Investigator: Stefan Böhme, MD         
Sub-Investigator: Frederic Tömböl         
Sub-Investigator: Irene Sulyok, MD         
Sub-Investigator: Valentin Heigert         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Roman Ullrich, MD Medical University of Vienna

Responsible Party: Dr. Roman Ullrich, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02121275     History of Changes
Other Study ID Numbers: LUS
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases