NCT02355405

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

January 30, 2015

Last Update Submit

April 17, 2015

Conditions

Keywords

lung ultrasoundatelectasisthoracic computed Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

lung ultrasound investigations were performed right before and after the surgical procedure.

thoracic CT were performed within one hour after the LUS investigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing selective neurosurgical operation in Xiangya Hospital or The Third Xiangya Hospital of Central South University

You may qualify if:

  • Aged 18 years and older;
  • American Society of Anesthesiologists (ASA) physical status within class I-III;
  • Scheduled for selective neurosurgical operation with general anesthesia;
  • Need of mechanical ventilation more than 2 hours;

You may not qualify if:

  • Patients decline to participate;
  • Pregnancy;
  • Previous thoracic procedures (thoracic drain, thoracotomy, thoracoscopy);
  • A history of pulmonary diseases within last two weeks with abnormal manifestation of lung CT (pulmonary parenchyma or/and interstitial lesions );
  • Pneumothorax or subcutaneous emphysema during peri-operation;
  • Patients with a body mass index (BMI) more than 30 kg/m2;
  • Emergency operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations