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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During induction of general anesthesia (up to five minutes after beginning of apnea) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During induction of general anesthesia (up to five minutes after beginning of apnea) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clínicas de Pernambuco | Recife | Pernambuco | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12827143 | Background | Arhem P, Klement G, Nilsson J. Mechanisms of anesthesia: towards integrating network, cellular, and molecular level modeling. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S40-7. doi: 10.1038/sj.npp.1300142. | |
| 21190458 | Background | Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available. |
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Ninety-eight patients were screened for the purpose of determining eligibility; seventy-two were enrolled, twenty-six were not due to not meeting the inclusion criteria [ASA >2,(01); Not Preschool-aged (21)], meeting the exclusion criteria [current upper respiratory tract infection(03)] or not signing the written informed consent (01)
Patients were recruited at the Teaching Hospital of the Federal University of Pernambuco
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| ID | Title | Description |
|---|---|---|
| FG000 | CPAP | 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 |
| FG001 | Control: Open System Ventilation | Open system ventilation: Facemask ventilation adapted to the anesthesia work station |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apnea Period |
|
| ||||||||||||||||||
| Recovery Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CPAP | 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 |
| BG001 | Control: Open System Ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | seconds | During induction of general anesthesia (up to five minutes after beginning of apnea) |
|
Five minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CPAP | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayme Marques dos Santos Neto | Anesthesiology Unit, Teaching Hospital of the Federal University of Pernambuco, Recife, Pernambuco, Brazil | 5581996212977 | jaymemed@yahoo.com.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 28, 2018 | Aug 28, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Open system ventilation | Device | Facemask ventilation adapted to the anesthesia work station |
|
| 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 | During induction of general anesthesia (up to five minutes after beginning of apnea) |
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| Background | Saklad M. Grading of patients for surgical procedures. Anesthesiology. 1941;2(3):281-284 |
| Background | ASA Physical Status Classification System. https://www.asahq.org/resources/clinical-information/asa-physical-status-classification-system. Published 2014 |
| NOT COMPLETED |
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Open system ventilation: Facemask ventilation adapted to the anesthesia work station |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists Physical Status | State based on the presence / absence of disease in the patients or on non-pathological physiological changes, as well as the quality of the control of morbidities. Ordinal variable whose categories are numbered in digits I to VI, with states I, absence of systemic disease, and II, systemic disease controlled | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | Seconds | During induction of general anesthesia (up to five minutes after beginning of apnea) |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | During induction of general anesthesia (up to five minutes after beginning of apnea) |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Control: Open System Ventilation | Open system ventilation: Facemask ventilation adapted to the anesthesia work station | 0 | 34 | 0 | 34 | 0 | 34 |
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| D012138 |
| Respiratory Therapy |