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THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation.

This technique has been successfully applied in several clinical settings (induction of general anesthesia, laryngoscopy in predicted difficult airway management, and as unique airway management technique for procedural sedation or general anesthesia for brief surgical procedures).

Operative hysteroscopy is a brief surgical procedure usually performed under general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through facial or laryngeal mask.

The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during hysteroscopy under general anesthesia. Our primary outcome is to describe the trend of SpO2 and tcCO2 during the procedures.

Secondary outcomes include description of arrhythmias requiring medical treatment, hemodynamic instability, unmanageable copious secretions, airway obstruction or inability to maintain airway patency, witnessed aspiration, airway related complications, number of airway manipulations, adverse events, assessment of postoperative dyspnoea and comfort, patient satisfaction.

Women (> 18 years old and < 70 years old), ASA physical status I and II presenting for elective operative hysteroscopies will be included.

A number of 30 patients was planned to target the primary outcome.

Обзор исследования

Статус

Завершенный

Подробное описание

Background Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE), term coined by Patel and Nouraei, refers to a technique that allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min using the Optiflow THRIVE-TM system (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand), in order to maintain viable gas exchange during an extended period of cessation of muscular activity.

Apnoeic oxygenation is a physiological phenomenon in which oxygen flow into the lungs is driven by a negative pressure gradient generated by the difference between the alveolar rates of oxygen absorption and carbon dioxide excretion.

Potentially rapid and dangerous rise in carbon dioxide concentration is prevented by the underlying mechanisms occurring during high-flow nasal oxygenation under apnoeic conditions.

As proposed by Slutsky and more recently by Hermez, cardiogenic oscillations (changes in airway gas flow and pressure synchronous with the cardiac cycle) and their interactions with supraglottic turbulence generated by high-flow nasal oxygenation might be the underlying mechanisms of THRIVE and of the enhanced clearance of carbon dioxide.

Many clinically relevant benefits have been associated with nasal high flow. It provides a constant FiO2 by delivering the gas at flow rates that exceed the patient's peak inspiratory flow rate. It is effective in providing a flow-dependent effect of continuous positive airway pressure of about 1 cmH20 for every 10 L/min increase in gas flow within a range of 30-50 L/min, up to 11.9 cm H20 at a maximum flow of 100 L/min. Moreover, it reduces respiratory rate, it clears in a dose-dependent manner dead space of the upper airways and possibly even below the soft palate, leading to a reduction in rebreathing of expired air, with the potential to increase the alveolar volume and to improve alveolar ventilation and gas exchange. It is likely that, especially in patients with mild to moderate respiratory failure, enhanced comfort from heated humidification and flushing of dead space, lessen the work of breathing, thus improving thoraco-abdominal synchrony. By contrast, in spontaneously breathing patients, as a consequence of the large amount of air inflated into the stomach, higher number of reflux events could be detected increasing the risks of aspiration.

This technique has been successfully applied in several clinical settings to extend the apnoeic window after the induction of general anesthesia and during laryngoscopy in predicted difficult airway management. As long as airway patency was present, it succeeded in extending the apnoeic window up to 65 minutes. PaO2 and peripheral oxygen saturation remained stable and the rate of rise of CO2 during apnoea was reduced from earlier findings of 0.5 kPa/min with conventional low-flow systems to 0.15 kPa/min.

THRIVE has also been used as unique airway management technique for procedural sedation or when general anesthesia was performed for brief surgical procedures: it was able to keep patients with mild systemic disease well oxygenated, maintaining PaO2 stable with decreased rates of rise of CO2 during apnoea, as compared to conventional low-flow systems for oxygen therapy, such as the Venturi mask.

Operative hysteroscopy is a brief surgical procedure (< 30 minutes), usually performed in a day-surgery regimen. Typical anesthesiologic management in this setting includes general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through laryngeal mask (I-gel). The application of THRIVE in this setting has potential advantages either for the patient, including minimal airway manipulation and greater comfort, either for the anesthesia provider, facilitating procedural technique and airway management.

Aim of the study The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during operative hysteroscopy under general anesthesia.

Monitoring Standard perioperative monitoring will include non-invasive blood pressure (NIBP) with an upper arm cuff, 3-lead ECG, peripheral oxygen saturation (SpO2) and bispectral index (BIS). NIBP will be measured every 5 minutes before induction of anesthesia and throughout the procedure. Transcutaneous carbon dioxide (tcCO2) will be continuously monitored by Radiometer TCM5 monitor.

Study protocol Upon arrival on the operating theatre, each patient will be placed in supine position in lithotomic position; a peripheral venous cannula will be inserted on the hand or forearm and 500 ml Ringer-Lactate solution infusion will be started. Omeprazole 40 mg and dexametasone 4 mg will be given preoperatively. 3 minutes of pre-oxygenation will be performed with 100% oxygen 30 L/min delivered via dedicated Optiflow THRIVE-TM nasal cannulae. General anesthesia will then be induced with target-controlled infusion (TCI) of propofol (7 mcg/kg) through Orchestra Infusion system (Fresenius Kabi) plus fentanyl (1,5 mcg/kg). The range of maintenance of propofol concentration will be 4-6 mcg/ml, titrated to maintain a level of anesthesia monitored by BIS between 40 and 50. With the onset of general anesthesia oxygen flow will be increased to 70 L/min and maintained throughout the procedure. Head repositioning, jaw thrust, oropharyngeal cannula placement could be used to improve airway patency during the procedure. In case of episodes of oxygen desaturation, defined as SpO2<94%, or rise of tcCO2 over 45 mmHg, positive pressure ventilation by facial mask or laryngeal mask will be applied by the practitioner based on clinical judgement.

At the end of the procedure, propofol will be stopped. Paracetamol 1g, ondansetron 4 mg and ketorolac 30 mg will be administered as routine clinical practice.

The awake patient will be moved to the PACU for three hours of post-operative monitoring as required by internal practice for day-surgery procedures. Standard monitoring will include NIBP measured every 15 minutes, 3-lead ECG, and peripheral oxygen saturation (SpO2).

One hour after the end of the procedure and before discharge from the PACU the patient will be asked to rate its perceived degree of dyspnoea with the Borg dyspnoea score and its degree of comfort by Visual Numerical Scale (VAS).

In case of episodes of oxygen desaturation, defined as SpO2<94%, supplemental oxygen will be initially provided to the patient by low-flow Venturi mask with FiO2 40%.

Discharge from the PACU will require an Aldrete score of 9-10.

Sample size calculation For this pilot study no sample size calculation was performed.

Тип исследования

Наблюдательный

Регистрация (Действительный)

30

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

      • Rome, Италия, 00168
        • IRCCS Policlinico Agostino Gemelli

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 70 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Метод выборки

Невероятностная выборка

Исследуемая популяция

Women scheduled for elective operative hysteroscopies will be included.

Описание

Inclusion Criteria:

  • ASA I-II.

Exclusion Criteria:

  • BMI > 30,
  • pregnancy,
  • cardiac arrhythmia,
  • high risk of aspiration,
  • neuromuscular disease,
  • patient refusal.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Наблюдательные модели: Только для случая
  • Временные перспективы: Перспективный

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
change of tCO2 during THRIVE ventilation.
Временное ограничение: pre-anesthesia; up to 1 hour.
CO2 values (reported as mmHg) measured by Radiometer monitor.
pre-anesthesia; up to 1 hour.
change of SpO2 during THRIVE ventilation.
Временное ограничение: pre-anesthesia; up to 1 hour.
SpO2 values (reported as "%") measured by oxymeter.
pre-anesthesia; up to 1 hour.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Airway related complications.
Временное ограничение: 2 hours after the end of anesthesia.
Incidence of patients requiring airway manipulations (nasal cannula, manual ventilation, laryngeal mask ventilation, tracheal intubation) by the anesthesiologist, reported as "% of total number of patients".
2 hours after the end of anesthesia.
Postoperative complications - 1
Временное ограничение: 2 hours after the end of anesthesia.
Incidence of patients suffering from cough, sore throat, dysphagia, dysphonia, laryngospasm, oxygen desaturation (defined as SpO2<94%), reported as "% of total number of patients"
2 hours after the end of anesthesia.
Postoperative complications - 2
Временное ограничение: 2 hours after the end of anesthesia.
Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea).
2 hours after the end of anesthesia.
Postoperative complications - 3
Временное ограничение: 2 hours after the end of anesthesia.
Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort).
2 hours after the end of anesthesia.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 февраля 2022 г.

Первичное завершение (Действительный)

1 апреля 2022 г.

Завершение исследования (Действительный)

1 мая 2022 г.

Даты регистрации исследования

Первый отправленный

19 января 2022 г.

Впервые представлено, что соответствует критериям контроля качества

21 марта 2022 г.

Первый опубликованный (Действительный)

22 марта 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 мая 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 мая 2022 г.

Последняя проверка

1 апреля 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Другие идентификационные номера исследования

  • 4631

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Общая анестезия

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