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- Ensaio Clínico NCT06770322
Comparação do efeito de dois métodos no edema laríngeo na inflação do manguito endotraqueal
Comparação dos métodos de medida convencional e manométrica na avaliação do edema laríngeo perioperatório pela USG em pacientes submetidos à cirurgia de estabilização lombar
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Atasehir
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Istanbul, Atasehir, Turquia (Türkiye), 34752
- Fatih Sultan Mehmet Training and Research Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
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. |
|
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. |
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measurement of airway column width
Prazo: 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 |
through study completion, an average of 6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Detection of complications due to postoperative laryngeal edema
Prazo: It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours
|
Detection of cough, dyspnea, dysphagia, dysphonia, dysphonia, facial edema that may occur after surgery for laryngeal edema. |
It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Arzu Yildirim Ar, As Prof, Fatih Sultan Mehmet Training and Research Hospital
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- AK 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/
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FSMTRH-MBN-01
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