Positive Pressure at Induction of Anesthesia in Children

NCT03432390 | Completed Results

• 1 other identifier: 79591417.0.0000.5201
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Continuous Positive Airway Pressure; Hypoxia; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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)

• Number of Participants That Experienced Complications While Undergoing General Anesthesia

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

Study Arms (2)

CPAP

EXPERIMENTAL

Device: Continuous Positive Airway Pressure

Control

ACTIVE COMPARATOR

Device: Open system ventilation

Interventions

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

CPAP

Open system ventilation DEVICE

Facemask ventilation adapted to the anesthesia work station

Control

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pre-school children, ASA physical status I or II, Children undergoing general anesthesia for elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

Hospital das Clínicas de Pernambuco

Recife, Pernambuco, Brazil

Location

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  BACKGROUND

• ASA Physical Status Classification System. https://www.asahq.org/resources/clinical-information/asa-physical-status-classification-system. Published 2014

  BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Jayme Marques dos Santos Neto
• Organization: Anesthesiology Unit, Teaching Hospital of the Federal University of Pernambuco, Recife, Pernambuco, Brazil

jaymemed@yahoo.com.br

5581996212977

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Clinical Professor

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 14, 2018
• Study Start: March 6, 2018
• Primary Completion: January 17, 2019
• Study Completion: May 23, 2019
• Last Updated: December 9, 2019
• Results First Posted: November 25, 2019

Record last verified: 2019-11

Locations

BR (1)