Continuous Positive Airway Pressure, General Anesthesia, Hypoxia
Conditions
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
Interventions
DEVICEContinuous 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
DEVICEOpen system ventilation
Facemask ventilation adapted to the anesthesia work station
Sponsors
Instituto Materno Infantil Prof. Fernando Figueira
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels | During induction of general anesthesia (up to five minutes after beginning of apnea) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry | During induction of general anesthesia (up to five minutes after beginning of apnea) | 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 | During induction of general anesthesia (up to five minutes after beginning of apnea) | 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 |
Countries
Brazil
Participant flow
Recruitment details
Patients were recruited at the Teaching Hospital of the Federal University of Pernambuco
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| Control: Open System Ventilation Open system ventilation: Facemask ventilation adapted to the anesthesia work station | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Apnea Period | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | Total | CPAP | Control: Open System Ventilation |
|---|---|---|---|
| Age, Continuous | 4.28 years STANDARD_DEVIATION 1.46 | 4.34 years STANDARD_DEVIATION 1.44 | 4.23 years STANDARD_DEVIATION 1.51 |
| American Society of Anesthesiologists Physical Status Physical Status I | 64 Participants | 31 Participants | 33 Participants |
| American Society of Anesthesiologists Physical Status Physical Status II | 4 Participants | 3 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Brazil | 68 participants | 34 participants | 34 participants |
| Sex: Female, Male Female | 16 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 52 Participants | 28 Participants | 24 Participants |
| Weight | 18.03 kilograms STANDARD_DEVIATION 4.7 | 18.28 kilograms STANDARD_DEVIATION 4.87 | 17.77 kilograms STANDARD_DEVIATION 4.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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
Time frame: During induction of general anesthesia (up to five minutes after beginning of apnea)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CPAP | Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels | 227.65 seconds |
| Controle | Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels | 133.68 seconds |
p-value: <0.0001t-test, 2 sided
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
Time frame: During induction of general anesthesia (up to five minutes after beginning of apnea)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CPAP | Number of Participants That Experienced Complications While Undergoing General Anesthesia | 0 Participants |
| Controle | Number of Participants That Experienced Complications While Undergoing General Anesthesia | 0 Participants |
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
Time frame: During induction of general anesthesia (up to five minutes after beginning of apnea)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CPAP | Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry | 38.65 Seconds |
| Controle | Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry | 43.12 Seconds |