NCT03802175

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 20, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 2, 2019

Last Update Submit

February 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Complications of Lung Ultrasound

    Pulmonary disease including atelectasis, pneumonia, pneumothorax and pleural effusion would be discovered by lung ultrasound

    20 minutes after tracheal extubation

Secondary Outcomes (1)

  • Comparison of Lung Ultrasound and Computed Tomography(CT)

    Within 1 hour after examnation of Lung Ultrasound

Other Outcomes (1)

  • Correlative Factors of Lung Ultrasound Score

    Through study completion, up to 8 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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℃

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Min Yan, Doctor

    Zhejiang University

    STUDY CHAIR

Central Study Contacts

Chen Xie, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 14, 2019

Study Start

January 10, 2019

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

February 20, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations