Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide

Not Applicable

Completed

• Conditions: Anesthesia Intubation Complication; Inhalation of Nitrous Oxide; Trachea; Adverse Effect of Other General Anesthetics
• Interventions: Device: Cylindrical-shape cuff ETT (Group C); Device: Tapered-shape cuff ETT (Group T)

• Registration Number: NCT01812915
• Lead Sponsor: DongGuk University

Brief Summary

When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.

TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.

Detailed Description

During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).

60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.

After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.

The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.

Study Timeline

• Study First Submitted: 2013-03-14
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-18
• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
• 18~70 years old
• American society of anesthesiologists physical status 1-2
• Body mass index < 30 kg/m2

Exclusion Criteria

• Contraindication for nitrous oxide
• Difficult intubation
• Cormack-Lehane grade > 3
• Airway-related or pulmonary diseases
• Short or long operation time (< 1 hour or > 3 hours)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cylindrical-shape cuff ETT (Group C)	Cylindrical-shape cuff ETT (Group C)	Control group: Mallinckrodt HiLo(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt Hi-Lo(TM) tube.
Tapered-shape cuff ETT (Group T)	Tapered-shape cuff ETT (Group T)	Experimental group: Mallinckrodt TaperGuard(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt TaperGuard(TM) tube.

Primary Outcome Measures

Name	Time	Method
Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide	One hour after the exposure to nitrous oxide under general anesthesia

Secondary Outcome Measures

Name	Time	Method
Postoperative sore throat: incidence	About 1, 6, 24 hours after termination of anesthesia
Postoperative dysphagia: incidence	About 1, 6, 24 hours after termination of anesthesia
Postoperative hoarseness: incidence	About 1, 6, 24 hours after termination of anesthesia
Intracuff pressure of the endotracheal tubes	0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide	Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany)

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of