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Fraction of Oxygen on Induction of Anesthesia in Infants (PEEP)

Primary Purpose

Apnea

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
positive end expiratory pressure
fraction of inspired oxygen 80%
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.

Exclusion Criteria:

  • Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.

Sites / Locations

  • Hee-Soo Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fraction of inspired oxygen 80%

Fraction of inspired oxygen 80% with positive end expiratory pressure

Arm Description

Outcomes

Primary Outcome Measures

apnea time
The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%

Secondary Outcome Measures

The incidence of significant atelectasis
the incidence of significant atelectasis (consolidation score ≥2) assessed by lung ultrasound.
Respiratory system compliance
Respiratory system compliance (ml/H2O) = tidal volume / (airway pressure at end inspiration-airway pressure at PEEP

Full Information

First Posted
January 20, 2021
Last Updated
July 10, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04722276
Brief Title
Fraction of Oxygen on Induction of Anesthesia in Infants
Acronym
PEEP
Official Title
The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia and Non-hypoxic Apnea Time in Infants: a Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Invesetigators evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants. Invesetigators assigned infants to a 7 cmH2O positive end expiratory pressure (PEEP) with fraction of inspired oxygen 80% or 0 cmH2O PEEP with fraction of oxygen 80% group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 80% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fraction of inspired oxygen 80%
Arm Type
Active Comparator
Arm Title
Fraction of inspired oxygen 80% with positive end expiratory pressure
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
positive end expiratory pressure
Intervention Description
7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia
Intervention Type
Other
Intervention Name(s)
fraction of inspired oxygen 80%
Intervention Description
fraction of inspired oxygen 80% applied during induction of anesthesia
Primary Outcome Measure Information:
Title
apnea time
Description
The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%
Time Frame
during face mask ventilation, maximum 3 minutes.
Secondary Outcome Measure Information:
Title
The incidence of significant atelectasis
Description
the incidence of significant atelectasis (consolidation score ≥2) assessed by lung ultrasound.
Time Frame
during anesthesia induction, maximum 5 minutes.
Title
Respiratory system compliance
Description
Respiratory system compliance (ml/H2O) = tidal volume / (airway pressure at end inspiration-airway pressure at PEEP
Time Frame
during anesthesia induction, maximum 5 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation. Exclusion Criteria: Neonates, former preterm infants with gestational age less than 60 weeks at the day of surgery, with previous history of respiratory disease, those with anticipated difficult mask ventilation or intubation and those with upper respiratory infection within 3 weeks were excluded.
Facility Information:
Facility Name
Hee-Soo Kim
City
Seoul
State/Province
Soul-t'ukpyolsi
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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Fraction of Oxygen on Induction of Anesthesia in Infants

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