Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position

Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.

The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.

Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Adverse Effects
• Intervention / Treatment: Device: endotracheal tube; Device: laryngeal mask

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, DK-2600
    • Glostrup University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for backsurgery of an espected duration less than 2 hours,
• Age 18-70 years,
• ASA (american society of anaaesthesiology) class 1-2,
• Normal airways

Exclusion Criteria:

• Body mass index >35
• Expected time of surgery > 2 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endotracheal group; airway management: endotracheal tube	Device: endotracheal tube; Unomedical endotracheal tube
Active Comparator: laryngeal mask group; airway management: laryngeal mask	Device: laryngeal mask; LMA Proseal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time of anaesthesia	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse effects using the 2 methods	2 years

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Study Chair: Karsten S Olsen, MD, DMSc

Publications and helpful links

General Publications

• Olsen KS, Petersen JT, Pedersen NA, Rovsing L. Self-positioning followed by induction of anaesthesia and insertion of a laryngeal mask airway versus endotracheal intubation and subsequent positioning for spinal surgery in the prone position: a randomised clinical trial. Eur J Anaesthesiol. 2014 May;31(5):259-65. doi: 10.1097/EJA.0000000000000004.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 30, 2009
• First Submitted That Met QC Criteria: December 30, 2009
• First Posted (Estimate): December 31, 2009

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 17, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: anaesthesia; prone position; laryngeal mask
• Other Study ID Numbers: Laryngeal mask or endotracheal