Fraction of Oxygen on Induction of Anesthesia in Infants

Apnea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722276
• Other study ID #: 2012-152-1184
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Apnea

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul	Soul-t'ukpyolsi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea time	The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%	during face mask ventilation, maximum 3 minutes.
Secondary	atelectasis score (0~72)	atelectasis score assessed by lung ultrasound (0-72)	during anesthesia induction, maximum 5 minutes.
Secondary	Number of participants with gastric air insufflation	presence of air in the gastric antrum	during anesthesia induction, maximum 5 minutes.