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

NCT01041352 | Completed

• 1 other identifier: Laryngeal mask or endotracheal
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anaesthesia; Adverse Effects

Keywords

anaesthesia; laryngeal mask; prone position

Outcome Measures

Primary Outcomes (1)

• time of anaesthesia

  2 years

Secondary Outcomes (1)

• adverse effects using the 2 methods

  2 years

Study Arms (2)

Endotracheal group

ACTIVE COMPARATOR

airway management: endotracheal tube

Device: endotracheal tube

laryngeal mask group

ACTIVE COMPARATOR

airway management: laryngeal mask

Device: laryngeal mask

Interventions

laryngeal mask DEVICE

LMA Proseal

laryngeal mask group

endotracheal tube DEVICE

Unomedical endotracheal tube

Endotracheal group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, DK-2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 24247413 DERIVED

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Karsten S Olsen, MD, DMSc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, DMSC

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: December 31, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

DK (1)