NCT03817177

Brief Summary

postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 2, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

January 23, 2019

Last Update Submit

March 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung sound score

    0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines 1. Moderate loss of lung aeration: multiple well-defined B lines (B1 lines) 2. Severe loss of lung aeration: multiple coalescent B lines (B2 lines) 3. Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air

    30 minutes after arrival of postanesthetic care unit

Study Arms (2)

nasal prong

PLACEBO COMPARATOR

conventional nasal prong application after the surgery in postanesthetic care unit (PACU)

Procedure: nasal prong

high flow nasal cannula oxygenation

EXPERIMENTAL

high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)

Procedure: high flow nasal cannula oxygenation

Interventions

high flow nasal cannula application in PACU

high flow nasal cannula oxygenation
nasal prongPROCEDURE

conventional nasal prong application in PACU

nasal prong

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • general anesthesia

You may not qualify if:

  • preterm
  • bronchopulmonary dysplasia
  • upper respiratory infection history
  • respiratory disease
  • cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Lee JH, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Application of a High-Flow Nasal Cannula for Prevention of Postextubation Atelectasis in Children Undergoing Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):474-482. doi: 10.1213/ANE.0000000000005285.

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Hee-Soo Kim

    Seoul National University Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee-Soo Kim, MD, Phd

CONTACT

Ji-Hyun Lee, MD, PHd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 25, 2019

Study Start

March 2, 2019

Primary Completion

January 30, 2021

Study Completion

June 30, 2021

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations