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Completed

NCT Number: NCT02384616

Hyperoxygenation in Anesthetized Children

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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Key information

Conditions

Hyperoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva Children's Hospital, Pediatric Anesthesia Unit

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Other

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

Primary outcomes

  1. Postoperative changes in lung volume in children receiving low (35%) or high (80%) intraoperative fraction of oxygen

    Time frame: 24 hours

    Measurement of end-expiratory lung volume by nitrogen wash-out technique

  2. Postoperative changes in airway resistance in children receiving low (35%) or high (80%) intraoperative fraction of oxygen

    Time frame: 24 hours

    Measurement of airway resistance and respiratory system elastance by forced oscillation technique

Secondary outcomes

  1. Respiratory complications

    Time frame: 1 month

    Assessing intraoperative (bronchospasm, laryngospasm, oxygen desaturation, airway obstruction) and postoperative (hypoxemia, atelectasis, pneumonia) complications

  2. Postoperative nausea and vomiting

    Time frame: 24 hours

Other outcomes

  1. Surgical site infection

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Walid HABRE

Other

Registry information

Official study title

Impact of Intraoperative High Inspired OXygen Fraction on Pulmonary Function, Surgical Site Infection, Postoperative Nausea and Vomiting in PEDiatric Anesthesia, the OXPED Study

Acronym: OXPED

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 10, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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