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Clinical Trials/NCT04722276
NCT04722276CompletedNot Applicable

The Effect of Positive End-expiratory Pressure During Induction of General Anesthesia and Non-hypoxic Apnea Time in Infants: a Randomized Controlled Trials

Seoul National University Hospital1 site in 1 country84 target enrollmentStarted: February 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
apnea time

Study Overview

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%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
1 Month to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

fraction of inspired oxygen 80%

Active Comparator

Intervention: fraction of inspired oxygen 80% (Other)

Fraction of inspired oxygen 80% with positive end expiratory pressure

Experimental

Intervention: positive end expiratory pressure (Other)

Outcomes

Primary Outcomes

apnea time

Time Frame: during face mask ventilation, maximum 3 minutes.

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

Secondary Outcomes

  • atelectasis score (0~72)(during anesthesia induction, maximum 5 minutes.)
  • Number of participants with gastric air insufflation(during anesthesia induction, maximum 5 minutes.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

professor

Seoul National University Hospital

Study Sites (1)

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