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Respiration and The Airway With Supraglottic Airway Devices

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スポンサー
Reham Ali Abdelhaleem Abdelrahman

キーワード

概要

The investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the Self Pressurized Airway Device with Blocker® with the ProsealTM Laryngeal Mask Airway (P-LMA)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. The investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( Pentex Corporation, Medical Division, Singapore)and assessment of any associated postoperative complications.
Hypothesis:
The investigators hypothesize that the self-pressurized air-Q with blocker has a greater seal pressure compared to Proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.

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 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.

日付

最終確認済み: 02/29/2020
最初に提出された: 12/13/2017
提出された推定登録数: 12/21/2017
最初の投稿: 12/26/2017
最終更新が送信されました: 03/04/2020
最終更新日: 03/08/2020
実際の研究開始日: 01/31/2018
一次完了予定日: 09/30/2019
研究完了予定日: 10/31/2019

状態または病気

Laryngeal Masks Comparison

介入/治療

Device: Self Pressurized Airway Device with Blocker

Device: Proseal Laryngeal Mask Airway

段階

-

アームグループ

介入/治療
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.

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
サンプリング方法Probability Sample
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. airway seal pressure [one year]

pressure at which leak starts to occur

2. fitting of the device against larynx [one year]

detected by the flexible fiberoptic

二次的な結果の測定

1. insertion time of the device [one year]

is defined as time in seconds from the chosen device touching the teeth to the first recorded near rectangular capnogram curve in the presence of satisfactory bilateral chest expansion.

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