Evaluation of Different Sizes of Left-Sided Double-Lumen Tubes for Thoracic Surgery in a Tertiary Level Teaching Hospital

Обзор

Double lumen tubes (DLT) have become standard of care for one lung ventilation in thoracic and esophageal surgeries. Selection of accurate size of DLT is important to achieve proper one lung ventilation, prevent trauma to airway, easy intubation, prevention of displacement of DLT and adequate oxygenation intraoperatively. There are no definitive guidelines to select the correct size of DLT. The aim of this study is to observe if there is any difference in the number of intubation attempts, intraoperative oxygenation and postoperative sore throat while using 35 Fr DLT size and other DLT size. The research will be conducted between Ashoj 1st 2082 to Chaitra 30 2082 at Manmohan Cardiothoracic Vascular and Transplant Center(MCVTC). Fifty patients aged more than eighteen years undergoing thoracic surgery requiring One Lung Ventilation(OLV) with left sided DLT will be selected for the study. Participants will be randomly assigned to 35 Fr DLT size group or DLT size group according to the height. Patients in both the groups will be given the samepreoperative care, intraoperative care and postoperative care. Besides patient's demography, diagnosis and operative procedure; number of intubation attempts, modified Cromack-Lehane(CL) grade, size of DLT, intraoperative oxygen saturation SpO₂ and postoperative sore throat on day of surgery and first postoperative day will be recorded. Statistical analysis will be done using t- test for independent variable, confidence interval for outcome of sore throat, significance of difference for number of male and female; rates, risk ratio and odds ratio will be calculated using 2x2 contingency table. P ≤ 0.05 will be considered statistically significant. Our expected outcome is 35 Fr DLT are easier to intubate, does not affect intraoperative oxygenation and decrease the incidence of postoperative sore throat.

Вмешательства

• Устройство Intubation of patients undergoing thoracic surgery with left sided double lumen tube
  During the intervention Integrity of the tracheal and bronchial cuffs will be checked first. Lubrication of the outside of the 35 Fr DLT will be done using 2.5% lidocaine jelly and intubating stylet will be inserted (can be preshaped to aid placement of the DLT). Direct laryngoscopy will be done to visualize the glottis. DLT will be advanced till the endobronchial cuff is passed beyond the vocal cords and then the stylet is removed. DLT will be rotated 90 anticlockwise and the tracheal cuff is i

Первичные конечные точки

• Ease of intubation using a 35 Fr DLT [Срок оценки: Day 1]
• Difference in intraoperative oxygenation between 35 Fr and different sizes of DLT [Срок оценки: Day 1]
• Postoperative sore throat [Срок оценки: Day 2]

Критерии участия

Критерии включения

• Patient aged 18 years or older undergoing thoracic surgery requiring OLV with placement of a left-sided DLT

Критерии исключения

• Patient refusal
• Need for rapid sequence intubation (RSI) due to increased aspiration risk
• Anticipated difficult intubation
• Emergency surgery
• Patient already intubated with a single-lumen ET tube
• DLT tube change to single lumen tube at the end and shifted with ETT in situ

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Nepal · 1 центр

• Manmohan Cardiothoracic Vascular and Transplant Centre — Kathmandu

Идентификаторы

NCT: NCT07373171 · 258/0821083

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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