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The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients

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ClinicalTrials.gov Identifier: NCT03802175
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Xuzhou Medical University
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date January 2, 2019
First Posted Date January 14, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date January 10, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2019)
Pulmonary Complications of Lung Ultrasound [ Time Frame: 20 minutes after tracheal extubation ]
Pulmonary disease including atelectasis, pneumonia, pneumothorax and pleural effusion would be discovered by lung ultrasound
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 10, 2019)
Comparison of Lung Ultrasound and Computed Tomography(CT) [ Time Frame: Within 1 hour after examnation of Lung Ultrasound ]
Lung ultrasound offers high sensitivity and specificity when compared with CT
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2019)
Correlative Factors of Lung Ultrasound Score [ Time Frame: Through study completion, up to 8 months ]
Higher score value represent more ventilation loss
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients
Official Title The Application Of Lung Ultrasound About Pulmonary Complications In Postoperative Hypoxemia Patients After General Anesthesia:A Prospective Observational Study
Brief Summary Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest radiography.The primary objective of the present study was to evaluate lung complications by bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in the postoperative period.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 8 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Parients in postoperative care unit(PACU) of 18 years at least and suffering from hypoxemia after general anesthesia and noncardiac surgeries were included in our study.
Condition Hypoxemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Xie C, Sun K, You Y, Ming Y, Yu X, Yu L, Huang J, Yan M. Feasibility and efficacy of lung ultrasound to investigate pulmonary complications in patients who developed postoperative Hypoxaemia-a prospective study. BMC Anesthesiol. 2020 Sep 1;20(1):220. doi: 10.1186/s12871-020-01123-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 10, 2019)
113
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- at least 18 years of age, hypoxemia after general anesthesia ( definded as a SPO2 <92%,greater than 30s)

Exclusion Criteria:

  • Covered with surgical dressings from opening thoracic and breast surgery, noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, unstable hemodynamics, dyspnea from residual opioids or muscle relaxants, hemoglobin of 8g/L or less, risk of bleeding, body temperature was more than 38℃ or less than 36℃
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chen Xie, Master 13252017900 1228617258@qq.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03802175
Other Study ID Numbers 2018-177
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Xuzhou Medical University
Investigators
Study Chair: Min Yan, Doctor Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date January 2019