NCT02584023

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

October 20, 2015

Last Update Submit

June 21, 2016

Conditions

Pulmonary Atelectasis

Keywords

ultrasonographyinfantperioperative periodgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative incidence of pulmonary atelectasis

    within the first day after the surgery

Secondary Outcomes (3)

  • Intraoperative incidence of pulmonary atelectasis after endotracheal intubation

    from the moment of endotracheal intubation until the end of surgery, up to 6 hours

  • Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)

    from the induction of general anesthesia until the end of the surgery, up to 6 hours

  • Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)

    within the first day after the surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

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.

Device: Lung ultrasound

Alveolar recruitment

ACTIVE COMPARATOR

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.

Device: Lung ultrasound

Interventions

Lung ultrasoundDEVICE

Lung ultrasound on both hemithorax in supine position

Alveolar recruitmentControl

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (6)

  • 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.

    PMID: 17238882BACKGROUND

  • 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.

    PMID: 12821566BACKGROUND

  • 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.

    PMID: 12502973BACKGROUND

  • 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.

    PMID: 23585400BACKGROUND

  • 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.

    PMID: 25620145BACKGROUND

  • 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.

    PMID: 24662376BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jin-Tae Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 22, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Locations

KR(1)