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Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

Primary Purpose

Pulmonary Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lung ultrasound
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Atelectasis focused on measuring ultrasonography, infant, perioperative period, general anesthesia

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minor surgery less than 2 hours under general anesthesia
  • Mechanically ventilated after endotracheal intubation

Exclusion Criteria:

  • History of surgery on the lungs
  • Laparoscopic surgery
  • Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
  • Considered inappropriate by the investigator

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Alveolar recruitment

Arm Description

No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery.

Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment.

Outcomes

Primary Outcome Measures

Postoperative incidence of pulmonary atelectasis

Secondary Outcome Measures

Intraoperative incidence of pulmonary atelectasis after endotracheal intubation
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)

Full Information

First Posted
October 20, 2015
Last Updated
June 21, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02584023
Brief Title
Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants
Official Title
Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
ultrasonography, infant, perioperative period, general anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery.
Arm Title
Alveolar recruitment
Arm Type
Active Comparator
Arm Description
Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment.
Intervention Type
Device
Intervention Name(s)
Lung ultrasound
Intervention Description
Lung ultrasound on both hemithorax in supine position
Primary Outcome Measure Information:
Title
Postoperative incidence of pulmonary atelectasis
Time Frame
within the first day after the surgery
Secondary Outcome Measure Information:
Title
Intraoperative incidence of pulmonary atelectasis after endotracheal intubation
Time Frame
from the moment of endotracheal intubation until the end of surgery, up to 6 hours
Title
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Time Frame
from the induction of general anesthesia until the end of the surgery, up to 6 hours
Title
Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
Time Frame
within the first day after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minor surgery less than 2 hours under general anesthesia Mechanically ventilated after endotracheal intubation Exclusion Criteria: History of surgery on the lungs Laparoscopic surgery Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia Considered inappropriate by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17238882
Citation
Lutterbey G, Wattjes MP, Doerr D, Fischer NJ, Gieseke J Jr, Schild HH. Atelectasis in children undergoing either propofol infusion or positive pressure ventilation anesthesia for magnetic resonance imaging. Paediatr Anaesth. 2007 Feb;17(2):121-5. doi: 10.1111/j.1460-9592.2006.02045.x.
Results Reference
background
PubMed Identifier
12821566
Citation
Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.
Results Reference
background
PubMed Identifier
12502973
Citation
Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
Results Reference
background
PubMed Identifier
23585400
Citation
Ashton-Cleary DT. Is thoracic ultrasound a viable alternative to conventional imaging in the critical care setting? Br J Anaesth. 2013 Aug;111(2):152-60. doi: 10.1093/bja/aet076. Epub 2013 Apr 12.
Results Reference
background
PubMed Identifier
25620145
Citation
Kiley S, Cassara C, Fahy BG. Lung ultrasound in the intensive care unit. J Cardiothorac Vasc Anesth. 2015 Feb;29(1):196-203. doi: 10.1053/j.jvca.2014.10.017. No abstract available.
Results Reference
background
PubMed Identifier
24662376
Citation
Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
Results Reference
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Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

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