Spinal StabilizationNCT06770322
Comparison of the Effect of Two Methods on Laryngeal Edema in Endotracheal Cuff Inflation
An observational study of Spinal Stabilization, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Stabilization
- What is being tested?
- Conventional and manometer
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 10 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-65 years with ASA physical status I-III undergoing elective lumbar stabilization surgery under general anesthesia in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Eligible patients were prospectively enrolled according to the predefined inclusion and exclusion criteria. Participants were categorized according to the endotracheal tube cuff management technique used as part of routine anesthetic care (conventional pilot balloon palpation or manometer-guided cuff management); no study-specific random allocation was performed.
Who may be able to join
- Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions
- Patients aged 18-65 years, included in the ASA I-III group
- Patients whose consent has been obtained
Who cannot join
- Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group
- Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
- Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries,
- Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year,
- Patients undergoing emergency surgery,
- Patients with advanced cardiac, renal, pulmonary and hepatic failure,
- Patients who did not give consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, 34752
About this study
Official title: Comparison of Conventional and Manometry Measurement Methods in the Evaluation of Perioperative Laryngeal Edema by USG in Patients Undergoing Lumbar Stabilization Surgery
In this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.
Read the detailed description
Lumbar spine surgery is commonly performed in the prone position. Although the prone position provides optimal surgical exposure, it may be associated with several physiological and position-related complications. Increased intra-abdominal and intrathoracic pressures may affect venous return and hemodynamics, while compression of the face, neck, and upper airway may contribute to facial and laryngeal edema. In addition, displacement, obstruction, or kinking of the endotracheal tube may occur after positioning.
Endotracheal tube cuff pressure represents another potential contributor to airway morbidity. The recommended cuff pressure is generally 25-30 cmH₂O. Excessive cuff pressure may impair tracheal mucosal perfusion and contribute to mucosal injury and postoperative airway symptoms. In conventional clinical practice, cuff inflation is often performed by manual palpation of the pilot balloon, whereas cuff manometry allows objective measurement and adjustment of cuff pressure.
Ultrasonographic measurement of laryngeal air column width (ACW) provides a non-invasive method for assessing peri-extubation changes in the upper airway. In this study, ACW is measured after tracheal intubation and again before extubation, and the pre-extubation/post-intubation ACW ratio is used to assess perioperative changes suggestive of laryngeal edema.
This prospective observational study evaluates peri-extubation laryngeal edema in adult patients undergoing elective lumbar stabilization surgery in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Participants are categorized according to the endotracheal tube cuff inflation technique used as part of routine anesthetic care: conventional pilot balloon palpation (Conventional group) or manometer-guided cuff inflation (Manometer group). No study-specific random allocation is performed, and the cuff inflation technique is determined as part of routine anesthetic practice rather than by the research protocol.
After standard monitoring and induction of general anesthesia, patients are intubated by direct laryngoscopy using an appropriately sized reinforced orotracheal tube. In the Conventional group, the endotracheal tube cuff is inflated manually according to the attending anesthesiologist's routine clinical practice, after which cuff pressure is measured using a cuff manometer and recorded. In the Manometer group, cuff pressure is adjusted to 25-30 cmH₂O using a cuff manometer. Thereafter, cuff pressure is measured and recorded at 30-minute intervals throughout the operation in both groups. In the Conventional group, cuff pressure is measured and recorded at these intervals without protocol-driven adjustment, whereas in the Manometer group, cuff pressure is readjusted to 25-30 cmH₂O when necessary.
Following intubation, laryngeal ACW is measured ultrasonographically in the transverse plane at the level of the cricothyroid membrane using a linear transducer. Patients are subsequently positioned prone with particular attention to avoiding pressure on the eyes, face, and neck. Mechanical ventilation is provided using volume-controlled ventilation with a tidal volume of 8 mL/kg, positive end-expiratory pressure of 5 cmH₂O, and a respiratory rate adjusted to maintain end-tidal carbon dioxide between 35 and 40 mmHg. General anesthesia is maintained with desflurane and remifentanil, with anesthetic agents titrated according to hemodynamic parameters and Patient State Index values. Routine hemodynamic and respiratory parameters are monitored and recorded throughout the procedure.
At the end of surgery, patients are returned to the supine position. Before extubation, laryngeal ACW is measured again using the same ultrasonographic technique. For ACW measurements, oral secretions are aspirated and the endotracheal tube cuff is deflated. After measurement, the cuff is reinflated to the appropriate pressure using a cuff manometer. The ACW ratio is calculated as the pre-extubation ACW divided by the post-intubation ACW.
After recovery from neuromuscular blockade and fulfillment of standard extubation criteria, patients are extubated and transferred to the post-anesthesia care unit. Postoperative airway-related symptoms, including cough, dyspnea, dysphagia, dysphonia, sore throat, and facial edema, are assessed during postoperative follow-up at 4, 8, and 24 hours after surgery.
- Conditions
- Spinal Stabilization
- Being tested
- Conventional, manometer
- Keywords
- ultrasonography, laryngeal edema, endotracheal cuff, lumbar spinal stabilization surgery
- Medical subject headings
- Laryngeal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalProcedure or surgery
The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.
manometerProcedure or surgery
The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. Receives: Procedure: Conventional | |
| Manometer | The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol. Receives: Procedure: manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of airway column width
Measurement of the effect of conventional and manometry methods on air column width by ultrasonography. With ultrasonography, laryngeal edema development can be observed in patients by measuring the air column width after intubation and before extubation in the transverse axis with a linear probe over the patient's cricothyroid membrane
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Detection of complications due to postoperative laryngeal edema
Detection of cough, dyspnea, dysphagia, dysphonia, dysphonia, facial edema that may occur after surgery for laryngeal edema.
Measured: It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal StabilizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Berkehan Nizamlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Arzu Yildirim Ar, As Prof, Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770322
- Sponsor's protocol ID
- FSMTRH-MBN-01
- Status last verified
- Sep 2026
- First submitted
- 28 Dec 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwee MM, Ho YH, Rozen WM. The prone position during surgery and its complications: a systematic review and evidence-based guidelines. Int Surg. 2015 Feb;100(2):292-303. doi: 10.9738/INTSURG-D-13-00256.1.
PubMed 25692433Oliveira VM, Weschenfelder ME, Deponti G, Condessa R, Loss SH, Bairros PM, Hochegger T, Daroncho R, Rubin B, Chiste M, Batista DC, Bassegio DM, Nauer Wda S, Piekala DM, Minossi SD, Santos VF, Victorino J, Vieira SR. Good practices for prone positioning at the bedside: Construction of a care protocol. Rev Assoc Med Bras (1992). 2016 May-Jun;62(3):287-93. doi: 10.1590/1806-9282.62.03.287.
PubMed 27310555Shriver MF, Zeer V, Alentado VJ, Mroz TE, Benzel EC, Steinmetz MP. Lumbar spine surgery positioning complications: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E16. doi: 10.3171/2015.7.FOCUS15268.
PubMed 26424340Bentsianov BL, Parhiscar A, Azer M, Har-El G. The role of fiberoptic nasopharyngoscopy in the management of the acute airway in angioneurotic edema. Laryngoscope. 2000 Dec;110(12):2016-9. doi: 10.1097/00005537-200012000-00007.
PubMed 11129012Manohar N, Ramesh VJ, Radhakrishnan M, Chakraborti D. Haemodynamic changes during prone positioning in anaesthetised chronic cervical myelopathy patients. Indian J Anaesth. 2019 Mar;63(3):212-217. doi: 10.4103/ija.IJA_810_18.
PubMed 30988536AK AK, Cascella M. Post-Intubation Laryngeal Edema. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560809/
PubMed 32809644Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. doi: 10.1136/bmj.288.6422.965.
PubMed 6423162Prinianakis G, Alexopoulou C, Mamidakis E, Kondili E, Georgopoulos D. Determinants of the cuff-leak test: a physiological study. Crit Care. 2005 Feb;9(1):R24-31. doi: 10.1186/cc3012. Epub 2004 Nov 29.
PubMed 15693963El-Baradey GF, El-Shmaa NS, Elsharawy F. Ultrasound-guided laryngeal air column width difference and the cuff leak volume in predicting the effectiveness of steroid therapy on postextubation stridor in adult. Are they useful? J Crit Care. 2016 Dec;36:272-276. doi: 10.1016/j.jcrc.2016.07.007. Epub 2016 Jul 16.
PubMed 27468680Abdel Wahab Abdelsattar Saleh Mohammad, Yara Ayman Iskandarani, Wael Mohammed Mossa, Maher A sheriff, Mohamrd Hamdi Alqassas. Comparative Study between Cuff Leak Test and Laryngeal U/S for Detection of Post Extubation Oedema in Prone Position Patient with General Anesthesia. J. Med. Chem. Sci., 2023, 6(11) 2686-2698.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Manometry Measurement Methods in the Evaluation of Perioperative Laryngeal Edema by USG in Patients Undergoing Lumbar Stabilization Surgery
- ClinicalTrials.gov ID
- NCT06770322
- Acronym / sponsor ID
- FSMTRH-MBN-01
- Conditions
- Spinal Stabilization
- Keywords
- ultrasonography, laryngeal edema, endotracheal cuff, lumbar spinal stabilization surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 13 Jan 2025 (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 this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.
Detailed description
Lumbar spine surgery is commonly performed in the prone position. Although the prone position provides optimal surgical exposure, it may be associated with several physiological and position-related complications. Increased intra-abdominal and intrathoracic pressures may affect venous return and hemodynamics, while compression of the face, neck, and upper airway may contribute to facial and laryngeal edema. In addition, displacement, obstruction, or kinking of the endotracheal tube may occur after positioning.
Endotracheal tube cuff pressure represents another potential contributor to airway morbidity. The recommended cuff pressure is generally 25-30 cmH₂O. Excessive cuff pressure may impair tracheal mucosal perfusion and contribute to mucosal injury and postoperative airway symptoms. In conventional clinical practice, cuff inflation is often performed by manual palpation of the pilot balloon, whereas cuff manometry allows objective measurement and adjustment of cuff pressure.
Ultrasonographic measurement of laryngeal air column width (ACW) provides a non-invasive method for assessing peri-extubation changes in the upper airway. In this study, ACW is measured after tracheal intubation and again before extubation, and the pre-extubation/post-intubation ACW ratio is used to assess perioperative changes suggestive of laryngeal edema.
This prospective observational study evaluates peri-extubation laryngeal edema in adult patients undergoing elective lumbar stabilization surgery in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Participants are categorized according to the endotracheal tube cuff inflation technique used as part of routine anesthetic care: conventional pilot balloon palpation (Conventional group) or manometer-guided cuff inflation (Manometer group). No study-specific random allocation is performed, and the cuff inflation technique is determined as part of routine anesthetic practice rather than by the research protocol.
After standard monitoring and induction of general anesthesia, patients are intubated by direct laryngoscopy using an appropriately sized reinforced orotracheal tube. In the Conventional group, the endotracheal tube cuff is inflated manually according to the attending anesthesiologist's routine clinical practice, after which cuff pressure is measured using a cuff manometer and recorded. In the Manometer group, cuff pressure is adjusted to 25-30 cmH₂O using a cuff manometer. Thereafter, cuff pressure is measured and recorded at 30-minute intervals throughout the operation in both groups. In the Conventional group, cuff pressure is measured and recorded at these intervals without protocol-driven adjustment, whereas in the Manometer group, cuff pressure is readjusted to 25-30 cmH₂O when necessary.
Following intubation, laryngeal ACW is measured ultrasonographically in the transverse plane at the level of the cricothyroid membrane using a linear transducer. Patients are subsequently positioned prone with particular attention to avoiding pressure on the eyes, face, and neck. Mechanical ventilation is provided using volume-controlled ventilation with a tidal volume of 8 mL/kg, positive end-expiratory pressure of 5 cmH₂O, and a respiratory rate adjusted to maintain end-tidal carbon dioxide between 35 and 40 mmHg. General anesthesia is maintained with desflurane and remifentanil, with anesthetic agents titrated according to hemodynamic parameters and Patient State Index values. Routine hemodynamic and respiratory parameters are monitored and recorded throughout the procedure.
At the end of surgery, patients are returned to the supine position. Before extubation, laryngeal ACW is measured again using the same ultrasonographic technique. For ACW measurements, oral secretions are aspirated and the endotracheal tube cuff is deflated. After measurement, the cuff is reinflated to the appropriate pressure using a cuff manometer. The ACW ratio is calculated as the pre-extubation ACW divided by the post-intubation ACW.
After recovery from neuromuscular blockade and fulfillment of standard extubation criteria, patients are extubated and transferred to the post-anesthesia care unit. Postoperative airway-related symptoms, including cough, dyspnea, dysphagia, dysphonia, sore throat, and facial edema, are assessed during postoperative follow-up at 4, 8, and 24 hours after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | – | Procedure: ConventionalThe endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. |
| Manometer | – | Procedure: manometerThe endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-65 years with ASA physical status I-III undergoing elective lumbar stabilization surgery under general anesthesia in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Eligible patients were prospectively enrolled according to the predefined inclusion and exclusion criteria. Participants were categorized according to the endotracheal tube cuff management technique used as part of routine anesthetic care (conventional pilot balloon palpation or manometer-guided cuff management); no study-specific random allocation was performed.
Key inclusion criteria (3 listed)
- Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions
- Patients aged 18-65 years, included in the ASA I-III group
- Patients whose consent has been obtained
Key exclusion criteria (7 listed)
- Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group
- Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
- Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries,
- Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year,
- Patients undergoing emergency surgery,
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 |
|---|---|---|
| ConventionalThe endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol. | Procedure or surgery | Conventional |
| manometerThe endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol. | Procedure or surgery | Manometer |
Primary outcome
Measurement of airway column width
Time frame: through study completion, an average of 6 months
Measurement of the effect of conventional and manometry methods on air column width by ultrasonography. With ultrasonography, laryngeal edema development can be observed in patients by measuring the air column width after intubation and before extubation in the transverse axis with a linear probe over the patient's cricothyroid membrane
1 secondary outcome
Detection of complications due to postoperative laryngeal edema
Time frame: It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours
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 22 Sep 2026.
- Background: PubMed 25692433Kwee MM, Ho YH, Rozen WM. The prone position during surgery and its complications: a systematic review and evidence-based guidelines. Int Surg. 2015 Feb;100(2):292-303. doi: 10.9738/INTSURG-D-13-00256.1.
- Background: PubMed 27310555Oliveira VM, Weschenfelder ME, Deponti G, Condessa R, Loss SH, Bairros PM, Hochegger T, Daroncho R, Rubin B, Chiste M, Batista DC, Bassegio DM, Nauer Wda S, Piekala DM, Minossi SD, Santos VF, Victorino J, Vieira SR. Good practices for prone positioning at the bedside: Construction of a care protocol. Rev Assoc Med Bras (1992). 2016 May-Jun;62(3):287-93. doi: 10.1590/1806-9282.62.03.287.
- Background: PubMed 26424340Shriver MF, Zeer V, Alentado VJ, Mroz TE, Benzel EC, Steinmetz MP. Lumbar spine surgery positioning complications: a systematic review. Neurosurg Focus. 2015 Oct;39(4):E16. doi: 10.3171/2015.7.FOCUS15268.
- Background: PubMed 11129012Bentsianov BL, Parhiscar A, Azer M, Har-El G. The role of fiberoptic nasopharyngoscopy in the management of the acute airway in angioneurotic edema. Laryngoscope. 2000 Dec;110(12):2016-9. doi: 10.1097/00005537-200012000-00007.
- Background: PubMed 30988536Manohar N, Ramesh VJ, Radhakrishnan M, Chakraborti D. Haemodynamic changes during prone positioning in anaesthetised chronic cervical myelopathy patients. Indian J Anaesth. 2019 Mar;63(3):212-217. doi: 10.4103/ija.IJA_810_18.
- Background: PubMed 32809644AK AK, Cascella M. Post-Intubation Laryngeal Edema. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560809/
- Background: PubMed 6423162Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. doi: 10.1136/bmj.288.6422.965.
- Background: PubMed 15693963Prinianakis G, Alexopoulou C, Mamidakis E, Kondili E, Georgopoulos D. Determinants of the cuff-leak test: a physiological study. Crit Care. 2005 Feb;9(1):R24-31. doi: 10.1186/cc3012. Epub 2004 Nov 29.
- Background: PubMed 27468680El-Baradey GF, El-Shmaa NS, Elsharawy F. Ultrasound-guided laryngeal air column width difference and the cuff leak volume in predicting the effectiveness of steroid therapy on postextubation stridor in adult. Are they useful? J Crit Care. 2016 Dec;36:272-276. doi: 10.1016/j.jcrc.2016.07.007. Epub 2016 Jul 16.
- BackgroundAbdel Wahab Abdelsattar Saleh Mohammad, Yara Ayman Iskandarani, Wael Mohammed Mossa, Maher A sheriff, Mohamrd Hamdi Alqassas. Comparative Study between Cuff Leak Test and Laryngeal U/S for Detection of Post Extubation Oedema in Prone Position Patient with General Anesthesia. J. Med. Chem. Sci., 2023, 6(11) 2686-2698.
- 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.
Arzu Yildirim Ar, As Prof study director
Fatih Sultan Mehmet Training and Research Hospital
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 Spinal Stabilization, run by Fatih Sultan Mehmet Training and Research Hospital 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 7 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 22 Sep 2026. 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?
Measurement of airway column width (time frame: through study completion, an average of 6 months). 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 NCT06770322, which also lists 10 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 22 Sep 2026.