Positive Pressure at Induction of Anesthesia in Children
Primary Purpose
Continuous Positive Airway Pressure, Hypoxia, General Anesthesia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure
Open system ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Continuous Positive Airway Pressure
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
Sites / Locations
- Hospital das Clínicas de Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CPAP
Control
Arm Description
Outcomes
Primary Outcome Measures
Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare the time between onset of apnea and the drop in 95% oxyhemoglobin saturation between the groups
Secondary Outcome Measures
Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The time to recovery of oxyhemoglobin saturation levels in pre-apnea pulse oximetry between groups
Number of Participants That Experienced Complications While Undergoing General Anesthesia
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The frequency of complications (laryngospasm, hypoxemia, bradycardia, cardiorespiratory arrest, death) between the groups
Full Information
NCT ID
NCT03432390
First Posted
February 7, 2018
Last Updated
November 25, 2019
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
1. Study Identification
Unique Protocol Identification Number
NCT03432390
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Positive Airway Pressure, Hypoxia, General Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
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
Intervention Name(s)
Open system ventilation
Intervention Description
Facemask ventilation adapted to the anesthesia work station
Primary Outcome Measure Information:
Title
Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels
Description
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare the time between onset of apnea and the drop in 95% oxyhemoglobin saturation between the groups
Time Frame
During induction of general anesthesia (up to five minutes after beginning of apnea)
Secondary Outcome Measure Information:
Title
Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry
Description
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The time to recovery of oxyhemoglobin saturation levels in pre-apnea pulse oximetry between groups
Time Frame
During induction of general anesthesia (up to five minutes after beginning of apnea)
Title
Number of Participants That Experienced Complications While Undergoing General Anesthesia
Description
In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The frequency of complications (laryngospasm, hypoxemia, bradycardia, cardiorespiratory arrest, death) between the groups
Time Frame
During induction of general anesthesia (up to five minutes after beginning of apnea)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hospital das Clínicas de Pernambuco
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Positive Pressure at Induction of Anesthesia in Children
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