Respiration and The Airway With Supraglottic Airway Devices
Ключавыя словы
Рэферат
Апісанне
The study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. The study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. The investigators will recruit 40 adult female(18-55 years old, ASAI&II) patients to a prospective randomized crossover clinical trial. Patients with history of upper respiratory tract infections, obstructive sleep apnea , potentially full stomach( trauma, morbid obesity BMI> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. All patients will be assessed pre-operatively El-Ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study.The patients will be randomly allocated into two groups(the SP-Blocker group & the P-LMA group; each group is 40 patients) using computer generated program . An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
Даты
Апошняя праверка: | 02/29/2020 |
Упершыню прадстаўлена: | 12/13/2017 |
Меркаваная колькасць заявак прадстаўлена: | 12/21/2017 |
Першае паведамленне: | 12/26/2017 |
Апошняе абнаўленне адпраўлена: | 03/04/2020 |
Апошняе абнаўленне апублікавана: | 03/08/2020 |
Фактычная дата пачатку даследавання: | 01/31/2018 |
Разліковая дата першаснага завяршэння: | 09/30/2019 |
Разліковая дата завяршэння даследавання: | 10/31/2019 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Device: Self Pressurized Airway Device with Blocker
Device: Proseal Laryngeal Mask Airway
Фаза
Групы ўзбраенняў
Рука | Ўмяшанне / лячэнне |
---|---|
Self Pressurized Airway Device with Blocker | Device: Self Pressurized Airway Device with Blocker used in adult low risk females undergoing elective gynecological operations |
Proseal Laryngeal Mask Airway | Device: Proseal Laryngeal Mask Airway used in adult low risk females undergoing elective gynecological operations. |
Крытэрыі прыдатнасці
Узрост, які мае права на вучобу | 18 Years Каб 18 Years |
Пол, прыдатны для навучання | Female |
Метад адбору проб | Probability Sample |
Прымае здаровых валанцёраў | Так |
Крытэрыі | Inclusion Criteria: - Adult female patients ASA I&II - Age: 18- 55 years old - BMI < 35 - Undergoing elective gynecological operations. Exclusion Criteria: - Patients with history of upper respiratory tract infections and obstructive sleep apnea. - Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation &heart burn, those with esophageal reflux or hiatus hernia. - Patients with coagulation disorders. - Patients with El-Ganzouri airway score ≥ 5 will. |
Вынік
Першасныя вынікі
1. airway seal pressure [one year]
2. fitting of the device against larynx [one year]
Меры другаснага выніку
1. insertion time of the device [one year]