Hyperoxygenation in Anesthetized Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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This study is aiming at assessing the effect of inspired oxygen fraction during general anesthesia on children's lung mechanics and volume. More specifically, the temporal change in end-expiratory lung volume (EELV) and respiratory system resistance and elastance during the perioperative period will be characterized in order to define the the effect of high inspired fraction of oxygen on lung function.

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Detailed Description

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High-enriched oxygen fractions (FiO2)are common practice during general anesthesia both to ensure normoxemia despite intrapulmonary shunts and to provide security in case of adverse events. However, high-inspired oxygen fraction may decrease ventilation-perfusion ratios and its benefits are still unproven in children.

The investigators aim at assessing the benefits and potential adverse effects of high-inspired oxygen fraction in two groups of children receiving either 30% FiO2 or 80% FiO2 during maintenance of anesthesia. Nitrogen multiple breath washout technique and forced oscillation technique will be used to measure end-expiratory lung volume (EELV) and airway resistance (Rrs) and respiratory elastance (Xrs) respectively. These measurements will be obtained before the general anesthesia, one hour and one day after the procedure.

Conditions

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Hyperoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group High FiO2

Children will receive Fi02 100% during induction of anesthesia until end tidal oxygen concentration (Et 02) of 90% before intubation, anesthesia will be maintained with Fi02 of 80%. Then, shortly before the planned extubation, Fi02 will be increased to 100%.

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.

Group Low FiO2

Children will receive Fi02 80% until Et 02 70% before intubation, anaesthesia will be maintained with Fi02 35%. Then, shortly before the planned extubation, Fi02 will be increased again to 80%.

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.

Interventions

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Oxygen

Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology (ASA) physical status I and II
* Body mass index \< 30 kg/m2
* Scheduled for elective surgery in the supine position lasting \< 200 min
* General Anesthesia with tracheal intubation

Exclusion Criteria

* Patients hospitalized more than 24 h before the operation
* History or clinical signs of heart or lung disease
* Upper respiratory tract infection \< 2 weeks prior to surgery
* Predictable difficult airway
* History of apnea
* Abdominal or thoracic surgery
* Lack of cooperation, language barrier

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes