Endotracheal TubeNCT05034666
Endotracheal Tube Cuff Inflation Pressure Varieties and Response to Education Among Anesthetists
A study testing Before the education program and After the education program in people with Endotracheal Tube, run by Suez Canal University at 1 site in Egypt.
Trial summary
Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Tube
- What is being tested?
- Before the education program and After the education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- anaesthetists
- works at Suez canal university hospital
- resident, registrar, or senior registrar
Who cannot join
- refusal to participate
- who will not complete the 2 rounds 3 readings each
Trial locations and contacts
1 site in 1 country.
About this study
Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients.
This study will investigate the endotracheal ETT cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply.
Read the detailed description
Although the increasing uses of different supraglottic devices as an alternative, the traditional endotracheal intubation is still considered the commonly used method for managing the airway of a generally anaesthetized patient. After passing the endotracheal tube through the larynx, the anaesthetist inflates the cuff or asks the anaesthesia technician to inflate it. How much air is injected into the cuff is not a major concern for almost all anaesthetists and they usually depend on palpating the external cuff tense to judge is it too much, accurate or not enough? Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. Inflation of the cuff of pressure more than 30 cm H2O can damage the tracheal mucosa by compromising capillary perfusion. When pressures are greater than 50 cm H2O, total obstruction of tracheal blood flow occurs. For long times, without any evidence-based data, it has been believed that well-trained anaesthetists are capable of determining proper ETT cuff pressures. It is presumed that anaesthetists can detect appropriate inflation pressure and overinflated ETT cuff by palpating the ETT pilot balloon. Adequacy of cuff inflation is conventionally determined by palpation of the external balloon. Previous studies suggest that this approach is unreliable. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. However, increased awareness of over-inflation risks may have improved recent clinical practice.
The aim of the work: This study will investigate the endotracheal cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply. Material and Methods: Type of the study: Prospective controlled single-blind study. Settings: After obtaining approval by the Ethics Committee of the Suez Canal University Hospital, and written informed consent with an explanation regarding the purpose, effects, technique, and complications, all anaesthetists, working currently in the facility, are included.
- Conditions
- Endotracheal Tube
- Being tested
- Before the education program, After the education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Before the education programBehavioural
Before applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.
After the education programBehavioural
After applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.
| Study group | Role | What they receive |
|---|---|---|
| Before education | Active comparator | Before alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff.
This is before applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure. Receives: Behavioral: Before the education program |
| After education | Active comparator | After alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff.
This is after applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure. Receives: Behavioral: After the education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy in inflating the cuff of the endotracheal tubes
assessment of the Anesthetists' accuracy in inflating the cuff of the endotracheal tubes used to maintain the airway of generally anaesthetized patients the change following feedback.
Measured: immediately after fixation of the endotracheal tube during general anaethesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jan 2018
- Primary completion1 Feb 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- anaesthetists of anaesthesia department on Suez canal university
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034666
- Sponsor's protocol ID
- ETT cuff pressure
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Tube Cuff Inflation Pressure Varieties and Response to Education Among Anesthetists
- ClinicalTrials.gov ID
- NCT05034666
- Acronym / sponsor ID
- ETT cuff pressure
- Conditions
- Endotracheal Tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 5 Sep 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.
Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients.
This study will investigate the endotracheal ETT cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply.
Detailed description
Although the increasing uses of different supraglottic devices as an alternative, the traditional endotracheal intubation is still considered the commonly used method for managing the airway of a generally anaesthetized patient. After passing the endotracheal tube through the larynx, the anaesthetist inflates the cuff or asks the anaesthesia technician to inflate it. How much air is injected into the cuff is not a major concern for almost all anaesthetists and they usually depend on palpating the external cuff tense to judge is it too much, accurate or not enough? Cuff pressure is essential in endotracheal tube management. Guidelines recommend a cuff pressure of 20 to 30 cm H2O. Inflation of the cuff of pressure more than 30 cm H2O can damage the tracheal mucosa by compromising capillary perfusion. When pressures are greater than 50 cm H2O, total obstruction of tracheal blood flow occurs. For long times, without any evidence-based data, it has been believed that well-trained anaesthetists are capable of determining proper ETT cuff pressures. It is presumed that anaesthetists can detect appropriate inflation pressure and overinflated ETT cuff by palpating the ETT pilot balloon. Adequacy of cuff inflation is conventionally determined by palpation of the external balloon. Previous studies suggest that this approach is unreliable. One study, for instance, found that cuff pressure exceeded 40 cm H2O in 40-to-90% of tested patients. However, increased awareness of over-inflation risks may have improved recent clinical practice.
The aim of the work: This study will investigate the endotracheal cuff inflation pressure applied by the participating anaesthetists, and their response after being informed about the pressure the participants will apply. Material and Methods: Type of the study: Prospective controlled single-blind study. Settings: After obtaining approval by the Ethics Committee of the Suez Canal University Hospital, and written informed consent with an explanation regarding the purpose, effects, technique, and complications, all anaesthetists, working currently in the facility, are included.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- anaesthetists of anaesthesia department on Suez canal university
| Arm | Type | Receives |
|---|---|---|
| Before education | Active comparator | Behavioral: Before the education programBefore alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff. This is before applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure. |
| After education | Active comparator | Behavioral: After the education programAfter alarming the participant anaesthetists about the pressure values of their practice in inflating the ETT cuff. This is after applying the intervention which is informing and educating the participant anaesthetists about the proper ETT cuff pressure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- anaesthetists
- works at Suez canal university hospital
- resident, registrar, or senior registrar
Key exclusion criteria (2 listed)
- refusal to participate
- who will not complete the 2 rounds 3 readings each
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 |
|---|---|---|
| Before the education programBefore applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists. | Behavioural | Before education |
| After the education programAfter applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists. | Behavioural | After education |
Primary outcome
accuracy in inflating the cuff of the endotracheal tubes
Time frame: immediately after fixation of the endotracheal tube during general anaethesia
assessment of the Anesthetists' accuracy in inflating the cuff of the endotracheal tubes used to maintain the airway of generally anaesthetized patients the change following feedback.
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 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Before the education program and After the education program in people with Endotracheal Tube, run by Suez Canal University at 1 site in Egypt.
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 2 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 Sep 2021. 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 Egypt. 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?
accuracy in inflating the cuff of the endotracheal tubes (time frame: immediately after fixation of the endotracheal tube during general anaethesia). 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 Sep 2021.