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

NCT00953433 | Completed

• 1 other identifier: Endoflex-Stylet
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation Complication; Anaesthesia

Keywords

Intratracheal

Outcome Measures

Primary Outcomes (1)

• Postoperative hoarseness

  1 hr postoperatively

Secondary Outcomes (15)

• 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

  72 hours postoperatively

• Multi Dimensional Voice Profile

  Preoperative - on average 12 hours before operation

Study Arms (2)

Endoflex tube

EXPERIMENTAL

Use of Endoflex tube for intubation.

Device: Endoflex tube

Endotracheal tube with stylet

ACTIVE COMPARATOR

Use of conventional endotracheal tube with a stylet for intubation.

Device: Polyvinyl chloride endotracheal tube with a stylet

Interventions

Endoflex tube DEVICE

Size decided upon gender.

Endoflex tube

Polyvinyl chloride endotracheal tube with a stylet DEVICE

Size decided upon gender.

Endotracheal tube with stylet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Study Officials

• Lars Rasmussen, MD, PHD

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 24, 2011

Record last verified: 2011-08

Locations

DK (1)