Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Endotracheal Tube Clinical Trial

Official title:

Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385044
• Other study ID #: J_In_2017-01
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: October 29, 2018

Study information

• Verified date: December 2018
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I, II

• Body mass index < 30 kg/m2

• Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position

Exclusion Criteria:

• History of airway-related or pulmonary diseases/abnormalities

• When difficult intubation is anticipated

• History of general anesthesia within the past 3 months

• Pregnancy

• History of smoking

Related Conditions & MeSH terms

• Endotracheal Tube

Intervention

Procedure:
• MOVT
ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
• VE/VI ratio of Spirometer
ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

Locations

Country	Name	City	State
Korea, Republic of	Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital	Goyang	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracuff Pressure	The intracuff pressure of endotracheal tube when cuff sealing is achieved.	From the start of cuff inflation to the airway sealing, an average of 2 minutes
Secondary	Intracuff air volume	The intracuff air volume of endotracheal tube when cuff sealing is achieved.	From the start of cuff inflation to the airway sealing, an average of 2 minutes