Comparison of the Effect of Two Methods on Laryngeal Edema in Endotracheal Cuff Inflation

NCT06770322 | Completed

• 1 other identifier: FSMTRH-MBN-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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 also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.

Conditions

Spinal Stabilization

Keywords

ultrasonography; laryngeal edema; endotracheal cuff; lumbar spinal stabilization surgery

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, an average of 6 months

Secondary Outcomes (1)

• Detection of complications due to postoperative laryngeal edema

  It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours

Study Arms (2)

Conventional

OTHER

According to the clinician's own practice, the cuff of the endotracheal intubation tube will be manually inflated with the help of a syringe and the pressure will be measured with manometry and a note will be taken.

Procedure: Conventional

Manometer

EXPERIMENTAL

The cuff pressure will be measured by manometry and the cuff of the endotracheal intubation tube will be inflated with 25-30 cmH2O.

Procedure: manometer

Interventions

Conventional PROCEDURE

According to the clinician's own practice, the cuff of the endotracheal intubation tube will be manually inflated with the help of a syringe and the pressure will be measured with manometry and a note will be taken.

Conventional

manometer PROCEDURE

The cuff pressure will be measured by manometry and the cuff of the endotracheal intubation tube will be inflated with 25-30 cmH2O.

Manometer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 25692433 BACKGROUND

• Oliveira 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.

  PMID: 27310555 BACKGROUND

• Shriver 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.

  PMID: 26424340 BACKGROUND

• Bentsianov 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.

  PMID: 11129012 BACKGROUND

• Manohar 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.

  PMID: 30988536 BACKGROUND

• AK AK, Cascella M. Post-Intubation Laryngeal Edema. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK560809/

  PMID: 32809644 BACKGROUND

• Seegobin 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.

  PMID: 6423162 BACKGROUND

• Prinianakis 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.

  PMID: 15693963 BACKGROUND

• El-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.

  PMID: 27468680 BACKGROUND

• Abdel 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.

  BACKGROUND

MeSH Terms

Conditions

Laryngeal Edema

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Arzu Yildirim Ar, As Prof

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Model Details: two groups with a conventional and manometry group

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 10, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)