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NCT Number: NCT01812915

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

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.

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Key information

Conditions

Adverse Effect of Other General Anesthetics Anesthesia Intubation Complication Inhalation of Nitrous Oxide Respiratory Tract Diseases Trachea Tracheal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Ilsan Hospital

Goyang, Gyeonggido, 10326, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cylindrical-shape cuff ETT (Group C)

Device

Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.

Other names: Mallinckrodt Hi-Lo(TM) endotracheal tube

Tapered-shape cuff ETT (Group T)

Device

Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.

Other names: Mallinckrodt TaperGuard(TM) endotracheal tube

Primary outcomes

  1. Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide

    Time frame: One hour after the exposure to nitrous oxide under general anesthesia

Secondary outcomes

  1. Intracuff pressure of the endotracheal tubes

    Time frame: 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide

    Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany)

  2. Postoperative sore throat: incidence

    Time frame: About 1, 6, 24 hours after termination of anesthesia

  3. Postoperative hoarseness: incidence

    Time frame: About 1, 6, 24 hours after termination of anesthesia

  4. Postoperative dysphagia: incidence

    Time frame: About 1, 6, 24 hours after termination of anesthesia

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2013
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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