Fraction of Oxygen on Induction of Anesthesia in Infants

NCT04722276 | Completed

• 1 other identifier: 2012-152-1184
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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%.

Conditions

Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• atelectasis score (0~72)

  during anesthesia induction, maximum 5 minutes.

• Number of participants with gastric air insufflation

  during anesthesia induction, maximum 5 minutes.

Study Arms (2)

fraction of inspired oxygen 80%

ACTIVE COMPARATOR

Other: fraction of inspired oxygen 80%

Fraction of inspired oxygen 80% with positive end expiratory pressure

EXPERIMENTAL

Other: positive end expiratory pressure

Interventions

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% with positive end expiratory pressure

fraction of inspired oxygen 80% OTHER

fraction of inspired oxygen 80% applied during induction of anesthesia

fraction of inspired oxygen 80%

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• We included paediatric patients aged 12 months or less about to receive general anaesthesia with endotracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Hee-Soo Kim

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

Location

MeSH Terms

Conditions

Apnea

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: February 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

KR (1)