Positive Pressure at Induction of Anesthesia in Children
NCT ID: NCT03432390
Last Updated: 2019-12-09
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
72 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-03-06
Study Completion Date
2019-05-23
Brief Summary
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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
Detailed Description
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Conditions
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Continuous Positive Airway Pressure
Hypoxia
General Anesthesia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
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CPAP
Group Type
EXPERIMENTAL
Continuous Positive Airway Pressure
Intervention Type
DEVICE
A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
Control
Group Type
ACTIVE_COMPARATOR
Open system ventilation
Intervention Type
DEVICE
Facemask ventilation adapted to the anesthesia work station
Interventions
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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
Intervention Type
DEVICE
Open system ventilation
Facemask ventilation adapted to the anesthesia work station
Intervention Type
DEVICE
Eligibility Criteria
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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
Minimum Eligible Age
2 Years
Maximum Eligible Age
6 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Instituto Materno Infantil Prof. Fernando Figueira
OTHER
Sponsor Role
lead
Responsible Party
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Flavia orange
PhD, Clinical Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Hospital das Clínicas de Pernambuco
Recife, Pernambuco, Brazil
Site Status
Countries
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Brazil
References
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BACKGROUND
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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79591417.0.0000.5201
Identifier Type: -
Identifier Source: org_study_id