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Идёт набор NCT05455723

Tracheal Tube Cuff Inflation-Deflation Method for Video Assisted Laryngoscope Nasal Intubation in Adults

Без фазы С лечением Airway Management Nasal Intubation Video Laryngoscope

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Inflation-deflation technique, Magill forceps technique.
Кому может быть актуально
Состояния в реестре: Airway Management, Nasal Intubation, Video Laryngoscope. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this clinical trial is to compare cuff inflation deflation method versus conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial that need nasal intubation. The study question: Is cuff inflation deflation method for nasal intubation takes a short time than the conventional method using Magill forceps in adult patients scheduled for elective surgery dental or maxillofacial? We will compare the inflation deflation technique with the Magill forceps technique for nasal intubation in adult patients to see if the inflation deflation technique will take less time and associated with less side effects like cuff perforation and mucosal injury. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Подробное описание

Magill forceps is used to maneuver the endotracheal tube (ETT) in the posterior oropharynx and place its tip into the laryngeal inlet. While the Magill forceps are useful in guiding the nasotracheal tube past the vocal cords, care must be taken to avoid excessive maneuvering in order to minimize the risk of local trauma and rupture of the nasotracheal tube balloon.

Cuff inflation-deflation method can reduce the apnea time in the adult patients. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.

Written informed consent will be obtained from all patients participating in the trial. The trial will be registered prior to patient enrollment. Ninety patients between the ages of 18 and 60 years with American Society of Anesthesiologists (ASA) physical status I -II , scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospective randomized observer blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or patient's refusal will be excluded from the study.

Materials and methods

Airway management is subdivided into phases:

Phase 1 :Passage of the endotracheal tube through the nose into the pharynx Phase 2 : Video-laryngoscope-guided passage of the endotracheal tube through the pharynx into the trachea.

Patients will be randomized into 2 groups according to phase 2:

Group A (45 patients) will be performed with tracheal tube cuff inflation-deflation method. Tracheal tube cuff will be inflated with 15-20 ml of air (volume of air is depending on the level of larynx). Once the tip of ETT at the laryngeal inlet, the cuff of ETT will be deflated and advanced into the trachea.

Group 2 (45 patients) will be performed using the Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.

Patients will be randomly assigned on a one-to-one ratio. Randomization will be performed outside the study center by means of a computer generated random- numbers table. Group allocation will be concealed in sealed opaque envelopes that will not be opened till the last practical moment.

The nasal intubation will be performed behind an opaque screen so that observer could not see which approach will be used. All procedures were performed preoperatively by the attending anesthetists, who have the same substantial expertise (at least 3 years) in the video laryngoscopy assisted nasal intubation in adult patients. Patient demographics, type and duration of surgery, and the patient's ASA physical status will be recorded.

Вмешательства

  • Процедура Inflation-deflation technique
    Inflation-Deflation Technique: The tracheal tube cuff will be inflated with 15-20 ml of air (volume of air is depending on the level of larynx). Once the tip of ETT at the laryngeal inlet, the cuff of ETT will be deflated and advanced into the trachea.
  • Процедура Magill forceps technique
    The Magill forceps to guide the ETT tip to pass through the pharynx and glottis into the trachea.

Первичные конечные точки

  • The time period for the second phase of nasal intubation [Срок оценки: Intraoperaotive]
Вторичные конечные точки (8)
  • to test whether the inflation-deflation method would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach. [Срок оценки: Intraoperaotive]
  • The number of attempts required for successful nasal intubation. [Срок оценки: Intraoperaotive]
  • Amount of injected air for cuff inflation [Срок оценки: Intraoperaotive]
  • Assessment of side effects of using Magill forceps during nasal intubation [Срок оценки: Intraoperaotive]
  • Evaluation of oxygenation state during nasal intubation [Срок оценки: preoperative and intraoperative]
  • evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation. [Срок оценки: 20 minutes after patient recovery]
  • Need for external compression and need for help [Срок оценки: Intraoperaotive]
  • need of endotracheal tube rotation [Срок оценки: Intraoperaotive]

Критерии участия

Критерии включения

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.

Критерии исключения

  • Patients, who have coagulopathies,
  • Have upper airway abnormalities,
  • At risk for aspiration or by reasons of
  • Parent's refusal will be excluded from the study

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
Профилактика

Центры проведения

Египет · 1 центр
  • Suez Canal University — Ismailia

Идентификаторы

NCT: NCT05455723 · 4523#

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗