Respiration and The Airway With Laryngeal Masks
キーワード
概要
説明
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 60 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 Baska Mask group & the I-gel group; each group is 30 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.
日付
最終確認済み: | 11/30/2018 |
最初に提出された: | 04/16/2018 |
提出された推定登録数: | 05/17/2018 |
最初の投稿: | 05/30/2018 |
最終更新が送信されました: | 12/26/2018 |
最終更新日: | 12/30/2018 |
実際の研究開始日: | 02/28/2019 |
一次完了予定日: | 07/31/2019 |
研究完了予定日: | 11/30/2019 |
状態または病気
介入/治療
Device: Baska Mask
Device: I-gel
段階
アームグループ
腕 | 介入/治療 |
---|---|
Active Comparator: Baska Mask It has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff over inflation, a known complication with other supraglottic airways. | Device: Baska Mask used in adult low risk females undergoing elective gynecological operations |
Active Comparator: I-gel The I-gel is a single use (SADs) composed of a soft ,gel-like, non-inflatable cuff made from a thermoplastic elastomer. It has a widened , flattened stem with a rigid bite block that acts as a buccal stabilizer to reduce axial rotation and mal-positioning and a port for gastric tube insertion. It is a latex free device that does not require digital insertion into mouth of patient. | Device: I-gel used in adult low risk females undergoing elective gynecological operations |
適格基準
研究の対象となる年齢 | 18 Years に 18 Years |
研究に適格な性別 | Female |
健康なボランティアを受け入れる | はい |
基準 | 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. |
結果
主な結果の測定
1. Oropharyngeal leak pressure [one year]
二次的な結果の測定
1. Insertion time needed for the placement of the device [one year]