Fraction of Oxygen on Induction of Anesthesia in Infants

Not Applicable

Completed

• Conditions: Apnea
• Interventions: Other: positive end expiratory pressure; Other: fraction of inspired oxygen 80%

• Registration Number: NCT04722276
• Lead Sponsor: Seoul National University Hospital

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Study Start: 2021-02-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fraction of inspired oxygen 80% with positive end expiratory pressure	positive end expiratory pressure	-
fraction of inspired oxygen 80%	fraction of inspired oxygen 80%	-

Primary Outcome Measures

Name	Time	Method
apnea time	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 Outcome Measures

Name	Time	Method
atelectasis score (0~72)	during anesthesia induction, maximum 5 minutes.	atelectasis score assessed by lung ultrasound (0-72)
Number of participants with gastric air insufflation	during anesthesia induction, maximum 5 minutes.	presence of air in the gastric antrum

Trial Locations

Locations (1)

Hee-Soo Kim; 🇰🇷 Seoul, Soul-t'ukpyolsi, Korea, Republic of