Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube

Lawson Health Research Institute

Status: Completed

Conditions: Endotracheal Intubation

Treatments: Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip); Device: Control - standard flexible ETT (Mallinckrodt)

Study type: Interventional

Funder types: Other

Identifiers

NCT01095861

R-09-126

16016 (Other Identifier)

Details and patient eligibility

About

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).

Full description

The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987)

The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003)

Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any adult patient scheduled for elective surgery.
• ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

Exclusion criteria

• Any patients with known or probable difficult airways.
• Any patient requiring rapid sequence induction.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups, including a placebo group

FlexTip ETT

Experimental group

Description:

FlexTip ETT

Treatment:

Device: FlexTip ETT (Parker FlexTip/GlideScope FlexTip)

Control

Placebo Comparator group

Description:

Standard Flexible ETT Mallinckrodt Hi-Lo cuffed tracheal tube Catalog # 86114 Mallinckrodt, ST. Louis, MO, 63134

Treatment:

Device: Control - standard flexible ETT (Mallinckrodt)