Positive Pressure at Induction of Anesthesia in Children

November 25, 2019 updated by: Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira

Continuous Positive Airway Pressure During General Anesthesia Induction For Elective Pediatric Surgery: Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Hospital das Clínicas de Pernambuco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Device: Open system ventilation
Facemask ventilation adapted to the anesthesia work station
Experimental: CPAP
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels
Time Frame: 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
During induction of general anesthesia (up to five minutes after beginning of apnea)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry
Time Frame: 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
During induction of general anesthesia (up to five minutes after beginning of apnea)
Number of Participants That Experienced Complications While Undergoing General Anesthesia
Time Frame: 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
During induction of general anesthesia (up to five minutes after beginning of apnea)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

January 17, 2019

Study Completion (Actual)

May 23, 2019

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 79591417.0.0000.5201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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