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Completed

NCT Number: NCT03385044

Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

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.

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Key information

Conditions

Endotracheal Tube

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Goyang, Gyeonggido, 10326, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MOVT

Procedure

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

Procedure

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.

Primary outcomes

  1. Intracuff Pressure

    Time frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes

    The intracuff pressure of endotracheal tube when cuff sealing is achieved.

Secondary outcomes

  1. Intracuff air volume

    Time frame: From the start of cuff inflation to the airway sealing, an average of 2 minutes

    The intracuff air volume of endotracheal tube when cuff sealing is achieved.

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2017
Registry last updated
Dec 14, 2018

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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