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Completed

NCT Number: NCT04722276

Fraction of Oxygen on Induction of Anesthesia in Infants

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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Key information

Conditions

Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hee-Soo Kim

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive end expiratory pressure

Other

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

Fraction of inspired oxygen 80%

Other

fraction of inspired oxygen 80% applied during induction of anesthesia

Primary outcomes

  1. 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

  1. atelectasis score (0~72)

    Time frame: during anesthesia induction, maximum 5 minutes.

    atelectasis score assessed by lung ultrasound (0-72)

  2. Number of participants with gastric air insufflation

    Time frame: during anesthesia induction, maximum 5 minutes.

    presence of air in the gastric antrum

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: PEEP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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