Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

NCT03385044 | Completed

• 1 other identifier: J_In_2017-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Tube

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intracuff air volume

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

Study Arms (2)

Cuff sealing by MOVT

ACTIVE COMPARATOR

MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured.

Procedure: MOVT

Cuff sealing by VE/VI ratio

ACTIVE COMPARATOR

VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured.

Procedure: VE/VI ratio of Spirometer

Interventions

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.

Cuff sealing by MOVT

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.

Cuff sealing by VE/VI ratio

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

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

Goyang, Gyeonggido, 10326, South Korea

Location

Study Officials

• Junyong In, MD, PhD

  DongGuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomization table of a treatment sequence will be managed by the third person who will not involve in this study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: March 12, 2018
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

KR (1)