NCT03432390

Positive Pressure at Induction of Anesthesia in Children

Continuous Positive Airway Pressure During General Anesthesia Induction For Elective Pediatric Surgery: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

Summary

SCENARIO: Hypoxemia is one of the most common adverse events during the induction of general anesthesia and may culminate with more serious complications such as cardiac arrest and death. Pediatric patients, due to their anatomical and physiological characteristics, are more likely to develop hemoglobin desaturation levels. Some preventive strategies are used during this period to reduce the chances of occurrence of adverse event. Continuous Positive Airway Pressure (CPAP) may be useful during anesthetic induction in delaying the drop in oxygen levels in the blood by increasing this body gas reserves. OBJECTIVES: To assess the effectiveness of CPAP during anesthetic induction in increasing apnea time until hemoglobin saturation falls to 95% in children undergoing general anesthesia for elective surgery. METHODS: Phase III, parallel, randomized clinical trial to be developed at the Teaching Hospital of the Federal University of Pernambuco. Patients (72) are divided into two groups (36 in each) in which all patients will spontaneously ventilate: group C will receive CPAP and group A will use the open system. Children of pre-school age with physical status I or II, according to the American Anesthesia Society, candidates for elective surgery under general anesthesia will be included. Patients with pre-existing parenchymal lung disease, cyanotic children or patients with oxyhemoglobin saturation \<95% prior to anesthetic induction and recent history (\<4 weeks) or active upper respiratory tract infection will be excluded. The descriptive statistical analysis will be carried out through measures of central tendency and dispersion for quantitative variables and via distribution of frequencies for qualitative variables. ETHICAL ASPECTS: This work will respect human rights, principles of bioethics, the resolution 466/2012 of the National Health Council and the statement from Helsinki. Submission and approval by the research ethics committee is required prior to data collection. KEYWORDS: Continuous Positive Airway Pressure, Hypoxia, General Anesthesia

Conditions

• Continuous Positive Airway Pressure
• Hypoxia
• General Anesthesia

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure	A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
DEVICE	Open system ventilation	Facemask ventilation adapted to the anesthesia work station

Timeline

• Start date: 2018-03-06
• Primary completion: 2019-01-17
• Completion: 2019-05-23
• First posted: 2018-02-14
• Last updated: 2019-12-09
• Results posted: 2019-11-25

Locations

1 site across 1 country: Brazil