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Completed

NCT Number: NCT01346384

Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide

The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologist physical status I or II
  • Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

Exclusion criteria

  • Height was < 155 or >180 cm (for the use of laryngeal tube size 4)
  • Body mass index ≥35 kg/m2
  • Preexisting laryngotracheal disease
  • Risk of pulmonary aspiration of gastric contents.

Treatment and study plan

laryngeal tube (VBM Medizintechnik)

Device

laryngeal tube number 4

Other names: The laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Primary outcomes

  1. intracuff pressure

    Time frame: 1-4 hours

    measured intracuff pressure of LT with N2O during intraoperative period

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 3, 2011
Registry last updated
May 5, 2011

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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