PEEP: Fraction of Oxygen on Induction of Anesthesia in Infants

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04722276
Collaborator
(none)
60
1
2
22.9
2.6

Study Details

Study Description

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%.

Condition or Disease Intervention/Treatment Phase
  • Other: positive end expiratory pressure
  • Other: fraction of inspired oxygen 80%
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: fraction of inspired oxygen 80%

Other: fraction of inspired oxygen 80%
fraction of inspired oxygen 80% applied during induction of anesthesia

Experimental: Fraction of inspired oxygen 80% with positive end expiratory pressure

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The incidence of significant atelectasis [during anesthesia induction, maximum 5 minutes.]

    the incidence of significant atelectasis (consolidation score ≥2) assessed by lung ultrasound.

  2. Respiratory system compliance [during anesthesia induction, maximum 5 minutes.]

    Respiratory system compliance (ml/H2O) = tidal volume / (airway pressure at end inspiration-airway pressure at PEEP

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hee-Soo Kim Seoul Soul-t'ukpyolsi Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04722276
Other Study ID Numbers:
  • 2012-152-1184
First Posted:
Jan 25, 2021
Last Update Posted:
Jan 4, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2022