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Trial Outcomes & Findings for Positive Pressure at Induction of Anesthesia in Children (NCT NCT03432390)

NCT ID: NCT03432390

Last Updated: 2019-12-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

During induction of general anesthesia (up to five minutes after beginning of apnea)

Results posted on

2019-12-09

Participant Flow

Patients were recruited at the Teaching Hospital of the Federal University of Pernambuco

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)

Participant milestones

Participant milestones
Measure
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
Control: Open System Ventilation
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Apnea Period
STARTED
36
36
Apnea Period
COMPLETED
34
34
Apnea Period
NOT COMPLETED
2
2
Recovery Period
STARTED
34
34
Recovery Period
COMPLETED
34
34
Recovery Period
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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
Control: Open System Ventilation
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Apnea Period
Protocol Violation
2
2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CPAP
n=34 Participants
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
Control: Open System Ventilation
n=34 Participants
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Total
n=68 Participants
Total of all reporting groups
Age, Continuous
4.34 years
STANDARD_DEVIATION 1.44 • n=34 Participants
4.23 years
STANDARD_DEVIATION 1.51 • n=34 Participants
4.28 years
STANDARD_DEVIATION 1.46 • n=68 Participants
Sex: Female, Male
Female
6 Participants
n=34 Participants
10 Participants
n=34 Participants
16 Participants
n=68 Participants
Sex: Female, Male
Male
28 Participants
n=34 Participants
24 Participants
n=34 Participants
52 Participants
n=68 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Brazil
34 participants
n=34 Participants
34 participants
n=34 Participants
68 participants
n=68 Participants
American Society of Anesthesiologists Physical Status
Physical Status I
31 Participants
n=34 Participants
33 Participants
n=34 Participants
64 Participants
n=68 Participants
American Society of Anesthesiologists Physical Status
Physical Status II
3 Participants
n=34 Participants
1 Participants
n=34 Participants
4 Participants
n=68 Participants
Weight
18.28 kilograms
STANDARD_DEVIATION 4.87 • n=34 Participants
17.77 kilograms
STANDARD_DEVIATION 4.58 • n=34 Participants
18.03 kilograms
STANDARD_DEVIATION 4.7 • n=68 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
CPAP
n=34 Participants
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
Controle
n=34 Participants
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels
227.65 seconds
Interval 198.08 to 257.21
133.68 seconds
Interval 109.11 to 158.24

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
CPAP
n=34 Participants
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
Controle
n=34 Participants
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry
38.65 Seconds
Interval 13.42 to 63.87
43.12 Seconds
Interval 21.26 to 64.99

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
CPAP
n=34 Participants
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
Controle
n=34 Participants
Open system ventilation: Facemask ventilation adapted to the anesthesia work station
Number of Participants That Experienced Complications While Undergoing General Anesthesia
0 Participants
0 Participants

Adverse Events

CPAP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control: Open System Ventilation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jayme Marques dos Santos Neto

Anesthesiology Unit, Teaching Hospital of the Federal University of Pernambuco, Recife, Pernambuco, Brazil

Phone: 5581996212977

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place