NCT03540940

Brief Summary

Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric patients arterial desaturation during induction of anesthesia develops rapidly, we studied the clinical benefit of PEEP applied during anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

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

May 17, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2019

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

May 17, 2018

Last Update Submit

August 14, 2019

Conditions

Pediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Duration of Apnea

    from the start of apnea until SpO2 reached 95%, maximum 5 minutes.

Study Arms (2)

zero positive end expiratory pressure

EXPERIMENTAL
Other: ZEEP

Positive end expiratory pressure

EXPERIMENTAL
Other: PEEP

Interventions

PEEPOTHER

7cmH2O positive end expiratory pressure

Positive end expiratory pressure
ZEEPOTHER

0 cmH2O positive end expiratory pressure

zero positive end expiratory pressure

Eligibility Criteria

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

You may qualify if:

  • pediatric patients undergoing general anesthesia using endotracheal intubation

You may not qualify if:

  • previous history of lung disease
  • anticipated difficulty in airway management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Kim EH, Lee JH, Jang YE, Ji SH, Cho SA, Kim JT, Kim HS. Effect of positive end-expiratory pressure during anaesthesia induction on non-hypoxic apnoea time in infants: A randomised controlled trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1012-1018. doi: 10.1097/EJA.0000000000001400.

    PMID: 33259454DERIVED

Study Officials

  • Hee-Soo Kim, Professor

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

May 21, 2018

Primary Completion

August 14, 2019

Study Completion

August 14, 2019

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

KR(2)