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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355405
Other study ID # XY3-LUS-8711
Secondary ID
Status Completed
Phase N/A
First received January 30, 2015
Last updated April 17, 2015
Start date January 2015
Est. completion date April 2015

Study information

Verified date April 2015
Source The Third Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative atelectasis and evaluating its severity in adult patients undergoing general anesthesia in the operating room.


Description:

Atelectases occur in up to 90% of patients undergoing general anesthesia and intubation. The aim of the present observational study was designed to further to evaluate the diagnostic performance of lung ultrasound (LUS) in detection of postoperative atelectasis in adult patients undergoing general anesthesia. Results of LUS as the experimental method will be compared to the results of computed tomography (CT) as the reference technique for the detection of atelectasis. The investigators want to confirm former findings of the appearance of perioperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Aged 18 years and older;

2. American Society of Anesthesiologists (ASA) physical status within class I-III;

3. Scheduled for selective neurosurgical operation with general anesthesia;

4. Need of mechanical ventilation more than 2 hours;

Exclusion Criteria:

1. Patients decline to participate;

2. Pregnancy;

3. Previous thoracic procedures (thoracic drain, thoracotomy, thoracoscopy);

4. A history of pulmonary diseases within last two weeks with abnormal manifestation of lung CT (pulmonary parenchyma or/and interstitial lesions );

5. Pneumothorax or subcutaneous emphysema during peri-operation;

6. Patients with a body mass index (BMI) more than 30 kg/m2;

7. Emergency operation.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
lung ultrasound
lung ultrasound investigations were performed right before and after the surgical procedure.
Radiation:
thoracic computed tomography
thoracic CT were performed within one hour after the LUS investigation

Locations

Country Name City State
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan

Sponsors (2)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between manifestations of atelectasis in lung ultrasound and in thoracic computed tomography. Measurements of lung ultrasound are performed before induction of anesthesia and immediately after finishing the surgery. Lung CTs are performed the day before surgery and within 1 hour after surgery. Outcome measure: comparison of atelectases by lung ultrasound (experimental method) versus by computed tomography (standard method) From 5 minutes before induction of anesthesia to 1 hour after the surgery Yes
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