NCT02499536

Brief Summary

The aim of this study is to find out relationship between PaO2/FiO2 and atelectasis finding on intraoperative lung ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

July 10, 2015

Last Update Submit

April 25, 2016

Conditions

Atelectasis, Postoperative

Keywords

AtelectasisPostoperativeLung ultrasound

Outcome Measures

Primary Outcomes (2)

  • Intraoperative lung ultrasound for atelectasis

    Lung ultrasound examination for atelectasis findings (eg. whether there is a loss of A line or presence of B lines before and after surgery)

    Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)

  • Change in PaO2/FiO2

    Arterial blood sampling to find out whether their is a change in PaO2/FiO2 before and after surgery.

    Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)

Secondary Outcomes (1)

  • Airway pressure change

    Baseline (Before surgery begins) and Postoperative (Just after the surgery ends)

Study Arms (1)

Study participants

EXPERIMENTAL

After general anesthesia development of the atelectasis will be investigated by the lung ultrasound

Device: ultrasound

Interventions

ultrasoundDEVICE

Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded.

Study participants

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20\~65
  • with ASA class 1 or 2
  • who are scheduled to undergo general anesthesia by using endotracheal intubation and arterial line cannulation

You may not qualify if:

  • The patients with abnormal chest x-ray finding,
  • pregnancy,
  • arrhythmia,
  • ischemic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, Gangnam-gu, 135-720, South Korea

Location

Related Publications (1)

  • Lichtenstein D, Meziere G, Seitz J. The dynamic air bronchogram. A lung ultrasound sign of alveolar consolidation ruling out atelectasis. Chest. 2009 Jun;135(6):1421-1425. doi: 10.1378/chest.08-2281. Epub 2009 Feb 18.

    PMID: 19225063BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ji young Kim, MD, PhD

    Department of anesthesiology and pain medicine, Gangnam Severance hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology and pain medicine

Study Record Dates

First Submitted

July 10, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 27, 2016

Record last verified: 2016-04

Locations

KR(1)