Oxygen Level and Safe Emergence From Anesthesia

Overview

Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.

Full Title of Study: “Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2013

Interventions

  • Procedure: 30% oxygen
  • Procedure: 100% oxygen

Arms, Groups and Cohorts

  • Experimental: 100% oxygen during extubation
    • In this arm the intervention will consist of 100 % oxygen.
  • Experimental: 30% oxygen during extubation
    • In this arm the intervention will consist of 30 % oxygen.

Clinical Trial Outcome Measures

Primary Measures

  • Area of atelectasis
    • Time Frame: 30 minutes
    • The area of atelectasis is investigated by computed tomography of the lungs postoperatively

Secondary Measures

  • Peripheral oxygen saturation (SpO2)
    • Time Frame: 3 hours
    • SpO2 is continuously assessed postoperatively.

Participating in This Clinical Trial

Inclusion Criteria

  • No sign of difficult airway or intubation – Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant. – Body mass index less than 35. – American Society of Anesthesiologists physical status (ASA) class I-III Exclusion Criteria:

  • Body mass index 35 or higher – Increased risk of aspiration – Obstructive sleep apnea syndrome – Procedures during surgery making a former easy airway a difficult airway – Need for opioids after extubation – Hypothermia

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Västmanland
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lennart Edmark, M.D. – Region Västmanland
  • Overall Official(s)
    • Mats Enlund, M.D., Ph.D., Principal Investigator, Landstinget i Värmland

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