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Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03385044
Enrollment
35
Registered
2017-12-28
Start date
2018-03-12
Completion date
2018-10-29
Last updated
2018-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube

Keywords

Endotracheal tube, Intracuff pressure, Minimal occlusive volume technique, Spirometer, Endotracheal sealing

Brief 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.

Interventions

PROCEDUREMOVT

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.

PROCEDUREVE/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.

Sponsors

DongGuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The randomization table of a treatment sequence will be managed by the third person who will not involve in this study.

Intervention model description

Two methods of cuff sealing will be applied in a random sequence to each patient.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intracuff PressureFrom the start of cuff inflation to the airway sealing, an average of 2 minutesThe intracuff pressure of endotracheal tube when cuff sealing is achieved.

Secondary

MeasureTime frameDescription
Intracuff air volumeFrom the start of cuff inflation to the airway sealing, an average of 2 minutesThe intracuff air volume of endotracheal tube when cuff sealing is achieved.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026