Deflated and Inflated Cuff Endotracheal Extubations

Официальное название

A Single-center, Patient- and Assessor-blinded, Randomized Controlled Trial to Compare Patient Outcomes Between Deflated and Inflated Cuff Endotracheal Extubations During Scheduled, Non-airway Surgery in Healthy Adults

Обзор

General anesthesia is a treatment with medicine to make a patient unconscious for surgery. This is sometimes called "being put to sleep" or "being put under." Most of the time, a breathing tube is used to help a machine breathe for patients. The breathing tube has a cuff, which is like a small balloon. After the breathing tube is placed, the cuff is inflated. This keeps the breathing tube in place and keeps fluids like saliva and stomach juices from getting into the windpipe and lungs. When a breathing tube is removed, that is called extubation. Normally, doctors deflate the cuff before removing the breathing tube. This is called deflated cuff extubation. Some doctors worry that keeping the cuff inflated while it is removed can damage the throat or vocal cords. However, some doctors keep the cuff inflated when removing the breathing tube. This is called inflated cuff extubation. These doctors think that keeping the cuff inflated can help keep fluids from entering the airway. Doctors have not studied if deflated cuff extubation is better or worse than inflated cuff extubation. The goal of this study is to see which type of extubation is better at keeping fluids from getting in the airway. Participants who are part of this study will get general anesthesia and have surgery as planned. Near the end of surgery, a small amount of liquid is placed at the back of a participant's mouth. This liquid is called contrast material, and it is like a dye. The contrast material will help determine if any liquid enters the windpipe or lungs. Then, contrast material is removed, along with any other fluids, using normal methods. When it is safe to take the breathing tube out, a deflated cuff extubation or an inflated cuff extubation will be performed. This decision will be made at random, like by the flip of a coin. Information will be collected about participants, the surgery, and how well a participant is breathing. After surgery, a chest x-ray will be taken to see if any of the contrast material is in the windpipe or lungs. Otherwise, everything else after surgery would be normal. 24 to 48 hours after surgery, a member of the research team will ask about any symptoms a participant may have, like sore throat or a hoarse voice. Research would conclude at that time.

Подробное описание

The current standard anesthetic practice for extubation is to deflate the endotracheal tube cuff using a syringe prior to extubation. While commonplace and nearly universally accepted, this practice is not based on evidence from randomized controlled trials but is instead due to concern for laryngeal or vocal cord injury and arytenoid cartilage dislocation. However, no publications exist in the medical literature that attribute laryngeal trauma directly to inflated cuff endotracheal tube extubation, as opposed to the process of extubation in general. To the contrary, case reports that describe peri operative extubation with unintentionally inflated cuffs all note the absence of negative outcome.

Alternatively, extubation with an inflated endotracheal tube cuff has been advocated as a technique to reduce airway complications in human and veterinary medicine. Tracheal aspiration, even micro-aspiration by oropharyngeal secretions, may increase the risk of pneumonia and other pulmonary complications. Based on an animal model, inflated cuff extubation may reduce airway contamination by oropharyngeal fluid. Additionally, leaving the endotracheal tube cuff inflated may effectively generate a vital capacity breath during extubation, maximizing oxygen reserves and facilitating a secretion-clearing cough. These theorized advantages may prolong the time to which supplemental oxygen is required as well as decrease airway/respiratory complications in the immediate post-extubation period. Within the intensive care setting, unplanned extubation (including accidental extubation and self-extubation) occurs at a rate of 3% to 16% of intubated patients or 0.1 to 3.6 per 100 days of mechanical ventilation. Estimates of national hospitalizations requiring mechanical ventilation approach 800,000, thereby placing the estimated number of unplanned extubations between 24,000 and 128,000. Presumably, the majority of these unplanned extubations are with inflated cuffs, and yet still no epidemic of laryngeal trauma from inflated cuff extubation exists. Furthermore, there have been no significant differences in laryngeal complications reported between planned and unplanned extubation in the intensive care population, suggesting that it is the endotracheal tube itself (and the process of placing it) that confers the risk of laryngeal complications, rather than the circumstances of its removal.

Though several providers have published their success with inflated cuff extubation, to date no prospective, randomized controlled trial has been performed directly comparing these two techniques. This study proposes to evaluate the effect of inflated cuff extubation on airway contamination by oropharyngeal material, extubation quality, post-extubation oxygenation, and laryngeal symptoms compared to the standard technique of deflated cuff extubation.

To assess the difference in aspiration rates between deflated and inflated cuff extubation, radio-opaque contrast material will be introduced into the oropharynx of intubated patients while under general anesthesia. The presence of this radio-opaque contrast at or below the level of the carina will be assessed with a chest radiograph taken postoperatively.

Вмешательства

• Процедура Inflated Cuff Extubation
  The adjustable pressure limiting valve will be set to 20 centimeters water pressure. To blind the Anesthesiologist Associate Investigator from the patient's group allocation, sham deflation of the endotracheal tube cuff pilot balloon will be performed with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure. In the rare event sign
• Процедура Deflated Cuff Extubation
  The adjustable pressure-limiting valve will be set to 20 centimeters water pressure. All air will be removed from the endotracheal tube cuff pilot balloon with a 10 milliliter syringe. The endotracheal tube will be withdrawn into an opaque blue towel, to prevent the Anesthesiologist Associate Investigator from identifying the patient's allocation, while the reservoir bag is simultaneously compressed to generate at least 20 centimeters water pressure positive airway pressure.

Первичные конечные точки

• Airway Contamination [Срок оценки: 0-30 minutes after arrival in the Post Anesthesia Care Unit]

Вторичные конечные точки (12)

• Hypoxemia [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Need for Supplemental Oxygen [Срок оценки: 0-6 minutes after tracheal extubation]
• Cough [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Obstruction [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Stridor [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Bronchospasm [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Laryngospasm [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Aspiration [Срок оценки: 0 to 6 minutes after tracheal extubation]
• Sore Throat [Срок оценки: 24-48 hours postoperatively]
• Cough [Срок оценки: 24-48 hours postoperatively]
• Voice Quality [Срок оценки: 24-48 hours postoperatively]
• Dysphagia [Срок оценки: 24-48 hours postoperatively]

Критерии участия

Критерии включения

• Adults aged 18 to 50 years old
• Scheduled for surgery, not of the airway, head, or neck, with anticipated case duration of less than 3 hours
• American Society of Anesthesiologists (ASA) Physical Status Classification of 1 to 3

Критерии исключения

• Emergent surgery, or surgery requiring prone, sitting or lateral positioning
• Pre-existing laryngeal pathology, obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infection, recent pneumonia, uncontrolled asthma, or uncontrolled gastroesophageal reflux disease
• Known difficulties with general anesthesia, such as prior anaphylactic reaction, difficult intubation or mask ventilation
• Known allergy to iohexol or a previous severe reaction to any contrast agents
• Unfavorable airway examination, such as Mallampati 4, limited mouth opening, and/or inability to extend neck
• Non-compliance with ASA Practice Guidelines for Preoperative Fasting
• Pregnancy
• Enrollment in another anesthesiology or surgery related interventional research study
• Surgeries scheduled on Friday or a day immediately prior to a holiday

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Naval Medical Center Camp Lejeune — Marine Corps Base Camp Lejeune

Публикации

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• Lasser EC, Lyon SG, Berry CC. Reports on contrast media reactions: analysis of data from reports to the U.S. Food and Drug Administration. Radiology. 1997 Jun;203(3):605-10. doi: 10.1148/radiology.203.3.9169676. PMID 9169676
• Caro JJ, Trindade E, McGregor M. The risks of death and of severe nonfatal reactions with high- vs low-osmolality contrast media: a meta-analysis. AJR Am J Roentgenol. 1991 Apr;156(4):825-32. doi: 10.2214/ajr.156.4.1825900. PMID 1825900
• Wolf GL, Arenson RL, Cross AP. A prospective trial of ionic vs nonionic contrast agents in routine clinical practice: comparison of adverse effects. AJR Am J Roentgenol. 1989 May;152(5):939-44. doi: 10.2214/ajr.152.5.939. PMID 2495706
• Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107. PMID 2343107
• Molfenter SM, Amin MR, Balou M, Herzberg EG, Frempong-Boadu A. A scoping review of the methods used to capture dysphagia after anterior cervical discectomy and fusion: the need for a paradigm shift. Eur Spine J. 2023 Mar;32(3):969-976. doi: 10.1007/s00586-022-07515-1. Epub 2023 Jan 10. PMID 36625955
• De Bodt MS, Wuyts FL, Van de Heyning PH, Croux C. Test-retest study of the GRBAS scale: influence of experience and professional background on perceptual rating of voice quality. J Voice. 1997 Mar;11(1):74-80. doi: 10.1016/s0892-1997(97)80026-4. PMID 9075179
• Ghio A, Revis J, Smithson-Barriere D, Jarze S, Giovanni A. Reliability and Correlations Between Overall Severity, Roughness and Breathiness in the Perception of Dysphonic Voices: Investigating Cognitive Aspects. J Voice. 2024 Jan;38(1):136-143. doi: 10.1016/j.jvoice.2021.07.010. Epub 2021 Aug 25. PMID 34452778

Идентификаторы

NCT: NCT06990308 · NMCCL.2025.0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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