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Endotracheal Tube Cuff PressureNCT05828342

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

An observational study of Endotracheal Tube Cuff Pressure and Loss of Resistance Syringe, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 yearsHealthy volunteers can take part
What is being tested?
Endotracheal tube cuff inflation with the loss of resistance syringe method
How many people
198 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jul 2022to 15 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Pediatric Population

Who may be able to join

  • -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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara City Hospital

    Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Use of the Loss-of-resistance Syringe Technique in Determining Endotracheal Cuff Measurements in Pediatric Patients

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:

Read more
  • 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).

Read the detailed description

Various complications related to endotracheal tube may develop after general anesthesia. Inflated cuffs at inappropriately high pressure reduce tracheal mucosal blood flow, causing ischemia and tracheal stenosis in the future. Cuffs that are inflated at lower pressures than necessary can cause inadequate ventilation and aspiration of stomach contents. Adequate endotracheal cuff pressure should be between 20-30 cmH2O. Cuff pressure should be kept around 25 cmH2O in critically ill intubated and mechanically ventilated patients. In critically ill patients, such as intensive care patients, contaminated secretions can leak from the tracheal cuff and cause ventilator-associated pneumonia. High cuff pressure increases the risk of tracheomalacia and tracheal dilatation in patients who are intubated for a long time.

Inflating the endotracheal cuff at the correct pressure is the main precaution in preventing complications such as tracheal stenosis. Cuff manometers are manual or automatic devices that measure pressure in endotracheal tube (ETT) or laryngeal mask airway (LMA) cuffs, and some may operate to maintain pressure at a certain level for extended periods of time. However, it is not always possible to understand that the endotracheal cuff is inflated at the correct pressure due to operating room insufficiencies. Not every operating room has a cuff manometer, and various manual techniques are used by anesthesiologists to inflate the endotracheal cuff without a cuff manometer. One of these techniques is the palpation technique applied by experienced anesthesiologists. However, this technique is known to have a high rate of errors. It has been shown that professional experience does not contribute to achieving the correct cuff pressure without pressure monitoring. Another technique is the "loss of resistance syringe technique". It aims to equalize the endotracheal cuff pressure to the tracheal lateral wall pressure by releasing the syringe piston after inflating the endotracheal cuff with a loss of resistance syringe, allowing the air pressure inside the cuff to push the syringe piston passively. This technique has been used previously in adult patients and has been proposed as an economical and easily accessible method for inflating the endotracheal cuff. There is no study in the literature on the use of this technique in pediatric patients.

In this study, investigators aimed to find out whether the resistance loss syringe technique is useful when adjusting the endotracheal cuff pressure in pediatric patients. Secondary aim of the study is to evaluate the measurements of two different manometers and to determine the margin of safety between the two manometers.

Benefit from research; the aim is to facilitate the inflation of the endotracheal cuffs of pediatric patients intubated under general anesthesia at the correct pressure and to prevent possible complications. The study does not have any risks other than possible general anesthesia risks.

This study is a clinical observational prospective study. Participants were patients between the ages of 0-18 who were anesthetized with standard general anesthesia method in the pediatric operating room and intubated with a cuffed endotracheal tube. Then, the cuff of the endotracheal tubes will be inflated with the epidural loss of resistance syringe, after that the syringe piston will be released, the syringe piston will be pushed back by the cuff pressure, and then the cuff pressures will be measured and recorded with the cuff manometer (VBM Cuff Pressure Gauge) and the cuff pressure measuring electronic injector (AG Cufill). A three-way vein valve will be used when making this measurement. During the measurement, an epidural loss of resistance syringe 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. The tube number of the patients will be determined according to the age-based formula and according to the anesthetist's prediction during intubation. Then it will be checked whether there is an air leak in the mechanical ventilator. The endotracheal tube cuff of patients with airway leakage will be inflated under the guidance of the cuff manometer so that there is no leakage.

Being tested
Endotracheal tube cuff inflation with the loss of resistance syringe method
Keywords
Airway, Cuff Pressure, Endotracheal Tube

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endotracheal tube cuff inflation with the loss of resistance syringe methodProcedure or surgery

    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.

Study groups in NCT05828342
Study groupRoleWhat they receive
Pediatric PatientsPatients 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.
Receives: Procedure: Endotracheal tube cuff inflation with the loss of resistance syringe method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 minute

  2. 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.

    Measured: 1 minute

Secondary outcomes (1)
  1. Pressure difference between different types of manometers

    The secondary aim of the study is to evaluate the measurements of two different manometers used in the clinic and to determine the margin of safety between the two manometers. Endotracheal cuff pressure will be recorded with two different manometers.

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start15 Jul 2022
  3. Primary completion15 Oct 2022
  4. Study completion15 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828342
Sponsor's protocol ID
E2-22-2060
Status last verified
Dec 2023
First submitted
12 Apr 2023
Last updated
14 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19244697
  • 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.

    PubMed 19112060
  • 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.

    PubMed 28737520

Questions about this trial

What is this clinical trial studying?

An observational study of Endotracheal Tube Cuff Pressure and Loss of Resistance Syringe, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure of the cuff inflated with the loss-of-resistance syringe technique (time frame: 1 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828342, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.

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