Clinical trial NCT03432390: Positive Pressure at Induction of Anesthesia in Children
Official title: Continuous Positive Airway Pressure During General Anesthesia Induction For Elective Pediatric Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Positive Airway Pressure
Hypoxia
General Anesthesia
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

* Pre-school children, ASA physical status I or II, Children undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Pre-existing parenchymal lung disease, Children cyanotic or with oxyhemoglobin saturation less than 95% before anesthetic induction, Recent history (\<4 weeks) or current upper respiratory tract infection

Primary outcomes:
measure: Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels
timeFrame: During induction of general anesthesia (up to five minutes after beginning of apnea)
Secondary outcomes:
measure: Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry
timeFrame: During induction of general anesthesia (up to five minutes after beginning of apnea)
measure: Number of Participants That Experienced Complications While Undergoing General Anesthesia
timeFrame: During induction of general anesthesia (up to five minutes after beginning of apnea)
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas de Pernambuco
state: Pernambuco
Study officials:
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