Laryngeal Morbidity After Endotracheal Intubation - Endoflex-tube Versus Use of Stylet

This study is aimed at reducing the risk of hoarseness and damage to the vocal cords following general anaesthesia. Conventional endotracheal intubation with use of a stylet will be compared with the Endoflex tube. A conventional stylet enforced endotracheal tube is dirigible because of the stiffness gained by the addition of a stylet. In high risk rapid sequence intubation settings the enhanced dirigibility can be crucial, which is why most anaesthesiologists choose to add the stylet in these situations. A new endotracheal tube with a dynamic dirigible end called the Endoflex tube might prove to be a good alternative to the conventional stylet enforced endotracheal tube.

Study hypothesis: The Endoflex tube will reduce the risk of hoarseness after intubation when compared to the conventional stylet enforced endotracheal tube under optimal intubation conditions.

Study Overview

• Status: Completed
• Conditions: Anaesthesia; Intubation Complication
• Intervention / Treatment: Device: Endoflex tube; Device: Polyvinyl chloride endotracheal tube with a stylet

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Elective surgical patients who require an endotracheal tube during general anaesthesia.
• Informed consent.
• Legally competent.
• Be able to understand Danish and be able to read the given information in Danish.

Exclusion Criteria:

• Planned or former operation in or around the pharynx or the larynx.
• Cancer, infection or sequelae in or around the pharynx or the larynx.
• Use of a stomach tube before or during surgery.
• Suspected difficult intubation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoflex tube; Use of Endoflex tube for intubation.	Device: Endoflex tube; Size decided upon gender.
Active Comparator: Endotracheal tube with stylet; Use of conventional endotracheal tube with a stylet for intubation.	Device: Polyvinyl chloride endotracheal tube with a stylet; Size decided upon gender.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative hoarseness	1 hr postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vocal cord sequelae		Preoperative - on average 12 hours before operation
Intubation conditions		During and after intubation - on average 5 minutes
Intubation difficulty scale		During and after intubation - on average 5 minutes
Voice Range Profile	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively
Multi Dimensional Voice Profile		Preoperative - on average 12 hours before operation
Voice Handicap Index		Preoperative - on average 12 hours before operation
Voice Range Profile	Only for the subgroup of patients with persisting hoarseness	After 4 weeks
Vocal cord sequelae		Within 24 hr postoperatively
Vocal cord sequelae	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively
Vocal cord sequelae	Only for the subgroup of patients with persisting hoarseness	After 4 weeks
Multi Dimensional Voice Profile		Within 24 hr postoperatively
Multi Dimensional Voice Profile	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively
Multi Dimensional Voice Profile	Only for the subgroup of patients with persisting hoarseness	After 4 weeks
Voice Handicap Index	Only for the subgroup of patients with persisting hoarseness	After 4 weeks
Voice Handicap Index	Only for the subgroup of patients with persisting hoarseness	72 hr postoperatively

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: TrygFonden, Denmark
• Investigators: Study Chair: Lars Rasmussen, MD, PHD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 5, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): August 24, 2011
• Last Update Submitted That Met QC Criteria: August 23, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Intratracheal
• Other Study ID Numbers: Endoflex-Stylet