Fraction of Oxygen on Induction of Anesthesia in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-07-01

Brief Summary

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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%.

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Detailed Description

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Conditions

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Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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fraction of inspired oxygen 80%

Group Type ACTIVE_COMPARATOR

fraction of inspired oxygen 80%

Intervention Type OTHER

fraction of inspired oxygen 80% applied during induction of anesthesia

Fraction of inspired oxygen 80% with positive end expiratory pressure

Group Type EXPERIMENTAL

positive end expiratory pressure

Intervention Type OTHER

7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia

Interventions

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positive end expiratory pressure

7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 80% applied during induction of anesthesia

Intervention Type OTHER

fraction of inspired oxygen 80%

fraction of inspired oxygen 80% applied during induction of anesthesia

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No