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

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953433
• Other study ID #: Endoflex-Stylet
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: August 23, 2011
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anaesthesia
• Intubation Complication

Intervention

Device:
• Endoflex tube
Size decided upon gender.
• Polyvinyl chloride endotracheal tube with a stylet
Size decided upon gender.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hoarseness		1 hr postoperatively	No
Secondary	Vocal cord sequelae		Preoperative - on average 12 hours before operation	No
Secondary	Intubation conditions		During and after intubation - on average 5 minutes	No
Secondary	Intubation difficulty scale		During and after intubation - on average 5 minutes	No
Secondary	Voice Range Profile	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively	No
Secondary	Multi Dimensional Voice Profile		Preoperative - on average 12 hours before operation	No
Secondary	Voice Handicap Index		Preoperative - on average 12 hours before operation	No
Secondary	Voice Range Profile	Only for the subgroup of patients with persisting hoarseness	After 4 weeks	No
Secondary	Vocal cord sequelae		Within 24 hr postoperatively	No
Secondary	Vocal cord sequelae	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively	No
Secondary	Vocal cord sequelae	Only for the subgroup of patients with persisting hoarseness	After 4 weeks	No
Secondary	Multi Dimensional Voice Profile		Within 24 hr postoperatively	No
Secondary	Multi Dimensional Voice Profile	Only for the subgroup of patients with persisting hoarseness	72 hours postoperatively	No
Secondary	Multi Dimensional Voice Profile	Only for the subgroup of patients with persisting hoarseness	After 4 weeks	No
Secondary	Voice Handicap Index	Only for the subgroup of patients with persisting hoarseness	After 4 weeks	No
Secondary	Voice Handicap Index	Only for the subgroup of patients with persisting hoarseness	72 hr postoperatively	No