The Effect of Cuff Pressure on Postoperative DysphagiaNCT05712135
Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases
An observational study of The Effect of Cuff Pressure on Postoperative Dysphagia, run by Ankara City Hospital Bilkent.
Trial summary
We aimed to measure the change in cuff pressure in different positions in neurosurgery cases and to investigate the effect of case length on cuff pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- The Effect of Cuff Pressure on Postoperative Dysphagia
- What is being tested?
- supine position, prone position and semi-fowler position
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 2 Jun 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurosurgery patients between the ages of 18-70 under general anesthesia in the operating room between February 2022 and April 2022.
Who may be able to join
- Neurosurgery patients between the ages of 18-70 ages
- American Society of Anesthesiologist score I-II-III-IV
Who cannot join
- Patients with previous tracheostomy
- Patients with tracheal stenosis
- Patients considered as difficult intubation
- Patients who have had more than one intubation attempt
- Patients with an ASA score greater than 4
- Patient who has difficulty understanding visual analog scale (VAS) scores
- Language / communication barrier
- Patients younger than 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
We aimed to measure the change in cuff pressure in different positions in neurosurgery cases and to investigate the effect of case length on cuff pressure.
Read the detailed description
It is an observational study, the cuffs of the endotracheal tubes of the patients who were intubated under general anesthesia between February 2023 and May 2023 will be inflated at 25 cm H2O pressure, and then the pressure line and the pilot balloon will be connected to the anesthesia monitor. The cuff pressure of the patient will be measured from the pilot balloon throughout the case and recorded at half-hour intervals. Postoperative sore throat will be evaluated on the VAS scale. Postoperative cough, hoarseness, and dysphagia symptoms will be evaluated.
- Being tested
- supine position, prone position, semi-fowler position
- Keywords
- cuff pressure, postoperative dysphagia, different positions in neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positionOther
The patient group whose cuff pressure was measured in the supine position
prone positionOther
The patient group whose cuff pressure was measured in the prone position
semi-fowler positionOther
The patient group whose cuff pressure was measured in the semi-fowler position
| Study group | Role | What they receive |
|---|---|---|
| supine | The patient group whose cuff pressure was measured in the supine position in neurosurgery Receives: Other: supine position | |
| prone | The patient group whose cuff pressure was measured in the prone position in neurosurgery Receives: Other: prone position | |
| semi-fowler | The patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery Receives: Other: semi-fowler position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of cuff pressure on postoperative sore throat
The primary outcome of the study was intubated under general anesthesia, endotracheal cuff of patients in supine, prone, semi-fowler position is to observe the change of pressures according to the positions.
Measured: 24 hours
Secondary outcomes (1)
Comparison of cuff pressure changes with cuff time according to groups
Secondary outcome of the study, case length on endotracheal cuff pressure is to observe.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion2 May 2023 (estimated)
- Study completion2 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of Cuff Pressure on Postoperative DysphagiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sena sarıcaoğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712135
- Sponsor's protocol ID
- E2-22-1369
- Status last verified
- Jan 2023
- First submitted
- 27 Nov 2022
- Last updated
- 3 Feb 2023
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases
- ClinicalTrials.gov ID
- NCT05712135
- Acronym / sponsor ID
- E2-22-1369
- Keywords
- cuff pressure, postoperative dysphagia, different positions in neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 2 May 2023 (estimated)
- Study completion
- 2 Jun 2023 (estimated)
- First posted
- 3 Feb 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.
We aimed to measure the change in cuff pressure in different positions in neurosurgery cases and to investigate the effect of case length on cuff pressure.
Detailed description
It is an observational study, the cuffs of the endotracheal tubes of the patients who were intubated under general anesthesia between February 2023 and May 2023 will be inflated at 25 cm H2O pressure, and then the pressure line and the pilot balloon will be connected to the anesthesia monitor. The cuff pressure of the patient will be measured from the pilot balloon throughout the case and recorded at half-hour intervals. Postoperative sore throat will be evaluated on the VAS scale. Postoperative cough, hoarseness, and dysphagia symptoms will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| supine | – | Other: supine positionThe patient group whose cuff pressure was measured in the supine position in neurosurgery |
| prone | – | Other: prone positionThe patient group whose cuff pressure was measured in the prone position in neurosurgery |
| semi-fowler | – | Other: semi-fowler positionThe patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgery patients between the ages of 18-70 under general anesthesia in the operating room between February 2022 and April 2022.
Key inclusion criteria (2 listed)
- Neurosurgery patients between the ages of 18-70 ages
- American Society of Anesthesiologist score I-II-III-IV
Key exclusion criteria (8 listed)
- Patients with previous tracheostomy
- Patients with tracheal stenosis
- Patients considered as difficult intubation
- Patients who have had more than one intubation attempt
- Patients with an ASA score greater than 4
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 |
|---|---|---|
| supine positionThe patient group whose cuff pressure was measured in the supine position | Other | supine |
| prone positionThe patient group whose cuff pressure was measured in the prone position | Other | prone |
| semi-fowler positionThe patient group whose cuff pressure was measured in the semi-fowler position | Other | semi-fowler |
Primary outcome
The effect of cuff pressure on postoperative sore throat
Time frame: 24 hours
The primary outcome of the study was intubated under general anesthesia, endotracheal cuff of patients in supine, prone, semi-fowler position is to observe the change of pressures according to the positions.
1 secondary outcome
Comparison of cuff pressure changes with cuff time according to groups
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of The Effect of Cuff Pressure on Postoperative Dysphagia, run by Ankara City Hospital Bilkent.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sena Sarıcaoglu Oktem, Resident (+90 538 600 2190, senasaricaoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of cuff pressure on postoperative sore throat (time frame: 24 hours). 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 3 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.