NCT02870842

Brief Summary

Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

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

First Submitted

Initial submission to the registry

August 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 14, 2016

Last Update Submit

August 23, 2017

Conditions

Pulmonary Atelectasis

Keywords

ultrasonographychildperioperative periodgeneral anesthesialung

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative atelectasis

    within the first day after the surgery

Secondary Outcomes (5)

  • Incidence of atelectasis after endotracheal intubation

    from the moment of endotracheal intubation until the end of surgery, up to 4 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 4 hours

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

    within the first day after the surgery

  • Postoperative incidence of fever (≥37.5℃)

    within the first day after the surgery

  • Postoperative incidence of respiratory complications

    within the first day after the surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia.

Device: Lung ultrasoundOther: Respiratory management

Low FiO2

ACTIVE COMPARATOR

Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia.

Device: Lung ultrasoundOther: Respiratory management

Interventions

Lung ultrasoundDEVICE

Lung ultrasound on both hemithorax in supine position

ControlLow FiO2
Respiratory managementOTHER

Appropriate respiratory managements depending on the lung ultrasound findings

ControlLow FiO2

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Expected operation time between 1 to 3 hours under general anesthesia
  • Mechanically ventilated after endotracheal intubation

You may not qualify if:

  • Cardiac, thoracic, abdominal surgery
  • 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, 110-744, South Korea

Location

Related Publications (4)

  • 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

  • Edmark L, Auner U, Enlund M, Ostberg E, Hedenstierna G. Oxygen concentration and characteristics of progressive atelectasis formation during anaesthesia. Acta Anaesthesiol Scand. 2011 Jan;55(1):75-81. doi: 10.1111/j.1399-6576.2010.02334.x. Epub 2010 Oct 29.

    PMID: 21039356BACKGROUND

  • Akca O, Podolsky A, Eisenhuber E, Panzer O, Hetz H, Lampl K, Lackner FX, Wittmann K, Grabenwoeger F, Kurz A, Schultz AM, Negishi C, Sessler DI. Comparable postoperative pulmonary atelectasis in patients given 30% or 80% oxygen during and 2 hours after colon resection. Anesthesiology. 1999 Oct;91(4):991-8. doi: 10.1097/00000542-199910000-00019.

    PMID: 10519502BACKGROUND

  • Martin JB, Garbee D, Bonanno L. Effectiveness of positive end-expiratory pressure, decreased fraction of inspired oxygen and vital capacity recruitment maneuver in the prevention of pulmonary atelectasis in patients undergoing general anesthesia: a systematic review. JBI Database System Rev Implement Rep. 2015 Sep 16;13(8):211-49. doi: 10.11124/jbisrir-2015-1410.

    PMID: 26455945BACKGROUND

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

August 14, 2016

First Posted

August 17, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

KR(1)