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

Adult Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346384
• Other study ID #: LT-N2O
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: May 3, 2011
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2011
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Disease

Intervention

Device:
• laryngeal tube (VBM Medizintechnik)
laryngeal tube number 4

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracuff pressure	measured intracuff pressure of LT with N2O during intraoperative period	1-4 hours	Yes