Loss-of-resistance Syringe Technique in Determining Endotracheal Cuff Pressure

NCT05828342 | Completed

• 1 other identifier: E2-22-2060
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about whether the loss-of-resistance syringe technique is beneficial when adjusting endotracheal cuff pressure in pediatric patients. The main questions it aims to answer are:

• Is the loss of resistance syringe technique useful when adjusting endotracheal cuff pressure in pediatric patients?
• Is there a difference between the measurements of two different cuff manometers used in the clinic, if so, what is the safety margin between the two manometers? The participants who will be operated under general anesthesia will be anesthetized with the standard anesthesia method, the cuffs of the endotracheal tubes will be inflated with an epidural loss of resistance syringe, the syringe piston will be released, and then the syringe piston will be pushed back with oscillation. Then, cuff pressures will be measured and recorded with a cuff manometer (VBM Cuff Pressure Gauge) and an electronic injector measuring cuff pressure (AG Cufill).

Conditions

Endotracheal Tube Cuff Pressure; Loss of Resistance Syringe; Airway Edema; Pediatric Population

Keywords

Airway; Cuff Pressure; Endotracheal Tube

Outcome Measures

Primary Outcomes (2)

• Pressure of the cuff inflated with the loss-of-resistance syringe technique

  The primary outcome is to find out whether the loss-of-resistance syringe technique is beneficial when adjusting endotracheal cuff pressure in pediatric patients. With this technique, it will be checked whether the cuff pressures inflated are between 20-30 cm H2O. Endotracheal cuff pressure will be recorded with manometer.

  1 minute

• Percentage of airway leak

  After the patients' endotracheal cuffs are inflated with a loss of resistance syringe, the mechanical ventilator will be checked for airway leakage. If there is a leak, the percentage of the leak will be recorded.

  1 minute

Secondary Outcomes (1)

• Pressure difference between different types of manometers

  1 minute

Study Arms (1)

Pediatric Patients

Patients under the age of 18 who were operated under general anesthesia and intubated with a cuffed endotracheal tube between 15 July 2022 and 15 October 2022 in the pediatric operating room.

Procedure: Endotracheal tube cuff inflation with the loss of resistance syringe method

Interventions

Endotracheal tube cuff inflation with the loss of resistance syringe method PROCEDURE

The cuffs of the endotracheal tubes will be inflated with the epidural loss of resistance syringe, the syringe piston will be released, the syringe piston will be pushed back with oscillation, and then the cuff pressures will be measured and recorded with a cuff manometer (VBM Cuff Pressure Gauge) and an electronic injector that measures cuff pressure (AG Cufill). A three-way vein valve will be used when making this measurement. During the measurement, an epidural resistance loss injector will be attached to one valve, a cuff manometer attached to another valve, and an electronic injector (AG Cufill) measuring cuff pressure to the third track. With this technique, the possibility of leakage due to insertion and removal during measurements will be eliminated.

Pediatric Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric Population

You may qualify if:

• Patients under the age of 18 who will be intubated and operated under general anesthesia in the pediatric operating room, whose informed consent form has been approved by their parents, between July 15, 2022 and October 15, 2022

You may not qualify if:

• \- Patients who are considered for difficult intubation, trachamalacia, laryngomalacia, tracheal surgery, or whose parental consent form has not been approved will be excluded from the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• Nseir S, Brisson H, Marquette CH, Chaud P, Di Pompeo C, Diarra M, Durocher A. Variations in endotracheal cuff pressure in intubated critically ill patients: prevalence and risk factors. Eur J Anaesthesiol. 2009 Mar;26(3):229-34. doi: 10.1097/eja.0b013e3283222b6e.

  PMID: 19244697 BACKGROUND

• Weiss M, Doell C, Koepfer N, Madjdpour C, Woitzek K, Bernet V. Rapid pressure compensation by automated cuff pressure controllers worsens sealing in tracheal tubes. Br J Anaesth. 2009 Feb;102(2):273-8. doi: 10.1093/bja/aen355. Epub 2008 Dec 25.

  PMID: 19112060 BACKGROUND

• Dubey M, Kumar Mittal A, Choudhary M. Loss of Resistance Syringe: A Substitute for Cuff Pressure Manometer. Anesth Analg. 2017 Aug;125(2):701-703. doi: 10.1213/ANE.0000000000002235. No abstract available.

  PMID: 28737520 BACKGROUND

Study Officials

• Sengul Ozmert

  Ankara CH Bilkent

  STUDY DIRECTOR

• Ayça T Dumanlı Ozcan

  Ankara CH Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: July 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

TU (1)