Endotracheal TubeNCT06353932
The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range
A study testing keeping the endotracheal tube cuff pressure within a certain range in people with Endotracheal Tube and Cuff Pressure, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube, Cuff Pressure, Sore Throat
- What is being tested?
- keeping the endotracheal tube cuff pressure within a certain range
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 25 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA ( american society of anesthesiologists) I-II-III group patients
- elective surgery
- surgery under general anesthesia
- gynecology and obstetrics and general surgery
Who cannot join
- Patients who did not agree to participate in the study,
- Patients under 18 years of age,
- Patients with ASA IV, V, VI,
- Patients scheduled for emergency surgery,
- Patients for whom difficult intubation is anticipated
- Patients who could not be intubated on the first try.
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- Patients with tracheostomy
- Thyroidectomy operations
- Parathyroidectomy operations
- COPD (Chronic Obstructive Pulmonary Disease) patients who have had an attack in the last 6 months
- Patients who complain of sore throat, hoarseness and cough before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range on the Incidence of Post-surgery Cough, Sore Throat, Hoarseness.
The main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups.
Read the detailed description
Although the safe cuff pressure range for high volume-low pressure tubes used today is defined as 20-30 cmH2O, routine cuff pressure monitoring is not performed in operating rooms. The aim of this study is to investigate whether there is a significant pressure difference between blindly inflated cuffs and the cuffs inflated by controlling the cuff pressure aided by monitorization, and the effects of any detected pressure difference on the trachea using the clinically detectable parameters of sore throat, hoarseness and cough. The patients included in this prospective, controlled, randomized, double-blind study were divided into two groups: the study group whose cuff pressures were monitored continously (n = 163) and the control group (n = 100). The study group was constantly monitored with an invasive pressure monitoring system. In addition, a researcher who was blind to the groups measured the endotracheal tube cuff pressure with the help of a manometer after intubation in both groups, before extubation, and in long-term cases, at the 3rd hour after intubation. Postoperatively, patients were evaluated for sore throat, cough, and hoarseness using VAS scoring at the 2nd and 24th hour by another researcher blinded to the study groups. Statistical evaluation was made using the Statistical Package for Social Sciences for Windows 20 (SPSS-IBM SPSS Inc., Chicago, IL) program. Complaint of sore throat was observed significantly less at 2nd and 24th hours in the group with cuff pressure monitoring (p=0.00 for 2nd hour sore throat, p=0.02 for 24th hour sore throat). No difference was detected between the groups in terms of hoarseness and cough. It has been observed that manometer measurements also reduce the pressure due to the use of air in the same closed system. The quantity of this reduction, which some researchers have previously stated, needs to be studied in more detail. In conclusion, intraoperative ETT cuff pressure monitoring may be effective in preventing sore throat and the mucosal ischemia that causes this pain.
- Conditions
- Endotracheal Tube, Cuff Pressure, Sore Throat
- Being tested
- keeping the endotracheal tube cuff pressure within a certain range
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keeping the endotracheal tube cuff pressure within a certain rangeOther
Also called measuring ETT cuff pressures with a manometer and continuous pressure monitor
The endotracheal tube cuff pressures of the study group patients were kept within the range of 20-25 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The endotracheal tubes of the control group were placed and inflated by the caregiver. A seperate blinded researcher measured cuff pressures by manometer but did not inform the team and no intervention was made. |
| study group | Active comparator | The endotracheal tube cuff pressures of the study group patients were constantly monitored and kept within the range of 20-25 cm H2O. Receives: Other: keeping the endotracheal tube cuff pressure within a certain range |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat
Blinded researcher using VAS (The Visual Analogue Scale) score to evaluate patient discomfort level.0-no pain, score <3 mild pain, 3-6 moderate pain, and >6 severe pain
Measured: second and 24th hours postoperatively
cough
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has a cough, no means she/he does not
Measured: second and 24th hours postoperatively
hoarseness
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has hoarseness, no means she/he does not
Measured: second and 24th hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start25 Jan 2024
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endotracheal TubeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kheyrana Mahmudova, Hacettepe University
- Investigators
- Murat İzgi, Ass. Prof., Principal investigator, Hacettepe University Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353932
- Sponsor's protocol ID
- KA-23026
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All checked supporting information is available, stored by the investigators. If
Publications
El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989Asai S, Motoyama A, Matsumoto Y, Konami H, Imanaka H, Nishimura M. Decrease in cuff pressure during the measurement procedure: an experimental study. J Intensive Care. 2014 Jun 2;2(1):34. doi: 10.1186/2052-0492-2-34. eCollection 2014.
PubMed 25908987Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
PubMed 20736432Yildirim ZB, Uzunkoy A, Cigdem A, Ganidagli S, Ozgonul A. Changes in cuff pressure of endotracheal tube during laparoscopic and open abdominal surgery. Surg Endosc. 2012 Feb;26(2):398-401. doi: 10.1007/s00464-011-1886-8. Epub 2011 Sep 10.
PubMed 21909860
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monitoring Endotracheal Tube Cuff Pressure and Keeping it in a Certain Range on the Incidence of Post-surgery Cough, Sore Throat, Hoarseness.
- ClinicalTrials.gov ID
- NCT06353932
- Acronym / sponsor ID
- KA-23026
- Conditions
- Endotracheal Tube, Cuff Pressure, Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 9 Apr 2024 (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 main purpose of our prospective, randomized, controlled, double-blind study is to investigate the effect of keeping endotracheal tube cuff pressures within a certain range on the incidence of postoperative sore throat, hoarseness and cough.The secondary aims of our study are to evaluate the effect of intubation duration, smoking, presence of chest disease, presence of blood on the intubation tube after extubation, presence of NG\OG, and type of surgery on the incidence of sore throat, hoarseness, and cough.The patients were randomly divided into two: a study group with continuous cuff pressure monitoring and a control group without continuous cuff pressure monitoring.The endotracheal cuff pressure of the patients in both groups was measured by a blinded researcher using a cuff manometer after intubation, before extubation, and in long cases, at the 3rd hour after intubation.Patients were evaluated for sore throat, cough, and hoarseness at the 2nd and 24th hours by another researcher blinded to the study groups.
Detailed description
Although the safe cuff pressure range for high volume-low pressure tubes used today is defined as 20-30 cmH2O, routine cuff pressure monitoring is not performed in operating rooms. The aim of this study is to investigate whether there is a significant pressure difference between blindly inflated cuffs and the cuffs inflated by controlling the cuff pressure aided by monitorization, and the effects of any detected pressure difference on the trachea using the clinically detectable parameters of sore throat, hoarseness and cough. The patients included in this prospective, controlled, randomized, double-blind study were divided into two groups: the study group whose cuff pressures were monitored continously (n = 163) and the control group (n = 100). The study group was constantly monitored with an invasive pressure monitoring system. In addition, a researcher who was blind to the groups measured the endotracheal tube cuff pressure with the help of a manometer after intubation in both groups, before extubation, and in long-term cases, at the 3rd hour after intubation. Postoperatively, patients were evaluated for sore throat, cough, and hoarseness using VAS scoring at the 2nd and 24th hour by another researcher blinded to the study groups. Statistical evaluation was made using the Statistical Package for Social Sciences for Windows 20 (SPSS-IBM SPSS Inc., Chicago, IL) program. Complaint of sore throat was observed significantly less at 2nd and 24th hours in the group with cuff pressure monitoring (p=0.00 for 2nd hour sore throat, p=0.02 for 24th hour sore throat). No difference was detected between the groups in terms of hoarseness and cough. It has been observed that manometer measurements also reduce the pressure due to the use of air in the same closed system. The quantity of this reduction, which some researchers have previously stated, needs to be studied in more detail. In conclusion, intraoperative ETT cuff pressure monitoring may be effective in preventing sore throat and the mucosal ischemia that causes this pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The endotracheal tubes of the control group were placed and inflated by the caregiver. A seperate blinded researcher measured cuff pressures by manometer but did not inform the team and no intervention was made. |
| study group | Active comparator | Other: keeping the endotracheal tube cuff pressure within a certain rangeThe endotracheal tube cuff pressures of the study group patients were constantly monitored and kept within the range of 20-25 cm H2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA ( american society of anesthesiologists) I-II-III group patients
- elective surgery
- surgery under general anesthesia
- gynecology and obstetrics and general surgery
Key exclusion criteria (11 listed)
- Patients who did not agree to participate in the study,
- Patients under 18 years of age,
- Patients with ASA IV, V, VI,
- Patients scheduled for emergency surgery,
- Patients for whom difficult intubation is anticipated
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 |
|---|---|---|
| keeping the endotracheal tube cuff pressure within a certain rangeAlso: measuring ETT cuff pressures with a manometer and continuous pressure monitorThe endotracheal tube cuff pressures of the study group patients were kept within the range of 20-25 cm H2O. | Other | study group |
Primary outcome
Sore throat
Time frame: second and 24th hours postoperatively
Blinded researcher using VAS (The Visual Analogue Scale) score to evaluate patient discomfort level.0-no pain, score <3 mild pain, 3-6 moderate pain, and >6 severe pain
cough
Time frame: second and 24th hours postoperatively
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has a cough, no means she/he does not
hoarseness
Time frame: second and 24th hours postoperatively
Blinded researcher using yes/no to evaluate patient discomfort. yes means the patient has hoarseness, no means she/he does not
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 9 Apr 2024.
- Results publication: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Results publication: PubMed 25908987Asai S, Motoyama A, Matsumoto Y, Konami H, Imanaka H, Nishimura M. Decrease in cuff pressure during the measurement procedure: an experimental study. J Intensive Care. 2014 Jun 2;2(1):34. doi: 10.1186/2052-0492-2-34. eCollection 2014.
- Results publication: PubMed 20736432Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
- Results publication: PubMed 21909860Yildirim ZB, Uzunkoy A, Cigdem A, Ganidagli S, Ozgonul A. Changes in cuff pressure of endotracheal tube during laparoscopic and open abdominal surgery. Surg Endosc. 2012 Feb;26(2):398-401. doi: 10.1007/s00464-011-1886-8. Epub 2011 Sep 10.
- Individual participant dataSharing planned: Yes. All checked supporting information is available, stored by the investigators. If
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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.
Murat İzgi, Ass. Prof. principal investigator
Hacettepe University Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing keeping the endotracheal tube cuff pressure within a certain range in people with Endotracheal Tube and Cuff Pressure, run by Hacettepe 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 4 inclusion and 11 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 9 Apr 2024. 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?
Sore throat (time frame: second and 24th hours postoperatively). The study lists 3 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 NCT06353932, which also lists 4 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 9 Apr 2024.