Endotracheal Tube Cuff PressureETTcPNCT05013658
Comparison of the Predictions of ETTcP With Pilot Balloon Palpation Among Anaesthesia Residents in Different Years
A study testing pressure measurement in people with Endotracheal Tube Cuff Pressure, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
In routine practice, pressure is often attempted to be adjusted by palpation of the cuff pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation of the reliability of the palpation method, which is widely used in cuff pressure measurement in the absence of a manometer, with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endotracheal Tube Cuff Pressure
- What is being tested?
- pressure measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2021to 1 Sep 2021
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergo elective operations with general anesthesia.
- Ages between 18-75
- ASA I-II-III patients
Who cannot join
- Patient refusal
- Patients with anticipated difficult airway
- Tempero-mandibular and atlanto-occipitac joint limitation
- Having ejection fraction less than 35%
- Peroperative nasogastric tube inserted patients
- Patients with a history of sore throat, hoarseness, difficulty swallowing before the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Predictions of Endotracheal Tube Cuff Pressure With Pilot Balloon Palpation and the Value Measured by Manometer Among Anaesthesia Residents in Different Education Years in the Department of Anesthesiology and Reanimation
In routine practice, pressure is often attempted to be adjusted by palpation of the cuff pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation of the reliability of the palpation method, which is widely used in cuff pressure measurement in the absence of a manometer, with clinical experience. Our recommendation is to use an accessible manometer if available.
Read the detailed description
After the patients were premedicated with an appropriate dose of midazolam, anesthesia was induced with propofol, fentanyl and rocuronium. Endotracheal intubation was performed after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex. We used 7.5 and 8.0 sizes of sterile ETTs are made of polyvinyl chloride and have a high-volume low-pressure cuffed design that conforms to the shape of the trachea. ETTs for female and male patients and before intubation Tracheal tubes (Tyco Healthcare©, Wollerau Switzerland) cuffs were tested for leakage. The researchers were divided into two groups of 20, with anaesthesia residents (anesthesia experience between 1 months and 1 year, Group J) and those with more than 4 years (Group S). The ETT was placed using the conventional intubation technique with a Macintosh laryngoscope after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex.. It was asked to swell with air up to cmH2O and a 10 ml injector was used for this. Then Direct pressure measurement was achieved by a cuff manometer calibrated in cmH2O, which was attached to the ETT pilot balloon. The participant was not informed about the actual pressure of cuff. Then the air in the cuff was completely evacuated and the same procedure was repeated with the participant from the other group, the agreement of the two groups to the target value of 25 cmH2O was compared. The order of priority among the groups was randomized according to the closed-envelope method. Controlled positive pressure ventilation was started after the measurement.
In cases in which the cuff pressure was above 30 cmH2O or below 20 cmH2O, the pressure was regulated back to normal limits. During the study, patients were in a supine, head and neck neutral position. Anesthesia was maintained as in our routine clinical practice.
- Conditions
- Endotracheal Tube Cuff Pressure
- Being tested
- pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure measurementBehavioural
pressure measurement with pilot balloon palpation
| Study group | Role | What they receive |
|---|---|---|
| junior | Active comparator | their anesthesia experiences are between 1 months and 1 year, Receives: Behavioral: pressure measurement |
| senior | Active comparator | Their anesthesia experiences are more than 4 years Receives: Behavioral: pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
experience difference
After intubation, first the assistant doctor with 0-1 year training period and then the assistant doctor with 4-5 years training period will be asked to inflate the cuff to approximately 25 cm H2O cuff pressure by palpation, and the pressure will be measured with a manometer and recorded.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start8 Jan 2021
- Primary completion25 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Cuff PressureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Çardaközü, Kocaeli University
- Investigators
- TÜLAY ÇARDAKÖZÜ, Principal investigator, KOCAELİ ÜNİVERSİTESİ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013658
- Sponsor's protocol ID
- manometer1
- Acronym
- ETTcP
- Status last verified
- Mar 2025
- First submitted
- 13 Aug 2021
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Predictions of Endotracheal Tube Cuff Pressure With Pilot Balloon Palpation and the Value Measured by Manometer Among Anaesthesia Residents in Different Education Years in the Department of Anesthesiology and Reanimation
- ClinicalTrials.gov ID
- NCT05013658
- Acronym / sponsor ID
- ETTcP / manometer1
- Conditions
- Endotracheal Tube Cuff Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Aug 2021 (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.
In routine practice, pressure is often attempted to be adjusted by palpation of the cuff pilot balloon of the endotracheal tube. The aim of our study is to investigate the variation of the reliability of the palpation method, which is widely used in cuff pressure measurement in the absence of a manometer, with clinical experience. Our recommendation is to use an accessible manometer if available.
Detailed description
After the patients were premedicated with an appropriate dose of midazolam, anesthesia was induced with propofol, fentanyl and rocuronium. Endotracheal intubation was performed after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex. We used 7.5 and 8.0 sizes of sterile ETTs are made of polyvinyl chloride and have a high-volume low-pressure cuffed design that conforms to the shape of the trachea. ETTs for female and male patients and before intubation Tracheal tubes (Tyco Healthcare©, Wollerau Switzerland) cuffs were tested for leakage. The researchers were divided into two groups of 20, with anaesthesia residents (anesthesia experience between 1 months and 1 year, Group J) and those with more than 4 years (Group S). The ETT was placed using the conventional intubation technique with a Macintosh laryngoscope after ensuring appropriate anaesthesia depth for intubation, by relaxation of the jaw and loss of eyelash reflex.. It was asked to swell with air up to cmH2O and a 10 ml injector was used for this. Then Direct pressure measurement was achieved by a cuff manometer calibrated in cmH2O, which was attached to the ETT pilot balloon. The participant was not informed about the actual pressure of cuff. Then the air in the cuff was completely evacuated and the same procedure was repeated with the participant from the other group, the agreement of the two groups to the target value of 25 cmH2O was compared. The order of priority among the groups was randomized according to the closed-envelope method. Controlled positive pressure ventilation was started after the measurement.
In cases in which the cuff pressure was above 30 cmH2O or below 20 cmH2O, the pressure was regulated back to normal limits. During the study, patients were in a supine, head and neck neutral position. Anesthesia was maintained as in our routine clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| junior | Active comparator | Behavioral: pressure measurementtheir anesthesia experiences are between 1 months and 1 year, |
| senior | Active comparator | Behavioral: pressure measurementTheir anesthesia experiences are more than 4 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergo elective operations with general anesthesia.
- Ages between 18-75
- ASA I-II-III patients
Key exclusion criteria (6 listed)
- Patient refusal
- Patients with anticipated difficult airway
- Having ejection fraction less than 35%
- Peroperative nasogastric tube inserted patients
- Patients with a history of sore throat, hoarseness, difficulty swallowing before the operation
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 |
|---|---|---|
| pressure measurementpressure measurement with pilot balloon palpation | Behavioural | junior, senior |
Primary outcome
experience difference
Time frame: four months
After intubation, first the assistant doctor with 0-1 year training period and then the assistant doctor with 4-5 years training period will be asked to inflate the cuff to approximately 25 cm H2O cuff pressure by palpation, and the pressure will be measured with a manometer and recorded.
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 5 Mar 2025.
- Individual participant dataSharing planned: No
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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.
TÜLAY ÇARDAKÖZÜ principal investigator
KOCAELİ ÜNİVERSİTESİ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure measurement in people with Endotracheal Tube Cuff Pressure, run by Kocaeli University 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 3 inclusion and 6 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 5 Mar 2025. 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?
experience difference (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.