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).
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
- Conditions the study is for
- Endotracheal Tube Cuff Pressure, Loss of Resistance Syringe, Airway Edema
- What is being tested?
- Endotracheal tube cuff inflation with the loss of resistance syringe method
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
- Conditions
- Endotracheal Tube Cuff Pressure, Loss of Resistance Syringe, Airway Edema, Pediatric Population
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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
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)
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.
- First posted25 Apr 2023
- Study start15 Jul 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Tube Cuff PressureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Yılmaz, Ankara City Hospital Bilkent
- Investigators
- Sengul Ozmert, Study director, Ankara CH BilkentAyça T Dumanlı Ozcan, Study director, Ankara CH Bilkent
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 19244697Weiss 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 19112060Dubey 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Loss-of-resistance Syringe Technique in Determining Endotracheal Cuff Measurements in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05828342
- Acronym / sponsor ID
- E2-22-2060
- Conditions
- Endotracheal Tube Cuff Pressure, Loss of Resistance Syringe, Airway Edema, Pediatric Population
- Keywords
- Airway, Cuff Pressure, Endotracheal Tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Patients | – | Procedure: Endotracheal tube cuff inflation with the loss of resistance syringe methodPatients 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pediatric Population
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal tube cuff inflation with the loss of resistance syringe methodThe 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. | Procedure or surgery | Pediatric Patients |
Primary outcome
Pressure of the cuff inflated with the loss-of-resistance syringe technique
Time frame: 1 minute
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.
Percentage of airway leak
Time frame: 1 minute
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 secondary outcome
Pressure difference between different types of manometers
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 19244697Nseir 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.
- Background: PubMed 19112060Weiss 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.
- Background: PubMed 28737520Dubey 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sengul Ozmert study director
Ankara CH Bilkent
Ayça T Dumanlı Ozcan study director
Ankara CH Bilkent
1 site in 1 country: see every site and its status.
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.