Esophageal Manometry During Recovery From Endotracheal Intubation
2026年7月30日 更新者:University of California, San Francisco
- An intact pharyngoesophageal reflex is essential to protect the upper airway from aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is essential at protecting the airway in all patients.
- In patients, while under medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
- With the cessation of anesthetics, accompanied by the reversal of nerve block, normal pharyngoesophageal peristaltic activity correlates with awakening the patient from anesthesia. This would be identified by the performance of esophageal manometry.
- A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This verbally stimulated swallowing sequence correlated precisely with the return of objective pharyngoesophageal function.
調査の概要
詳細な説明
The emergence from routine general deep anesthesia with an endotracheal tube is a potentially dangerous time for patients.
Patients cannot reliably maintain competence of the upper esophageal sphincter, thus aspiration of the contents from the mouth or regurgitated material from the stomach can be aspirated into the lungs leading to serious complications.
In normal awake individuals the upper esophageal sphincter (also known as the cricopharyngeus or the inferior pharyngeal constrictor) is contracted and relaxes precisely timed with voluntary or involuntary swallowing.
The swallowing sequence in normal awake persons begins with 1) the contraction of the upper and middle pharyngeal constrictors, 2) the posterior movement of the tongue and 3) the prompt relaxation of the contracted upper esophageal sphincter.
Peristalsis then begins in the body of the esophagus leading contents to the stomach.
The above is the normal sequence in humans, a process which maintains absolute separation of the airway and digestive passageways despite being in intimate proximity.
During the early period of emergence from anesthesia, the aspiration risk is highest due to the sluggish return of the resting pressure in the upper esophagus and the lack of normal coordination with involuntary swallowing.
Thus patients can't protect their airway by maintaining competence and appropriate relaxation of the upper esophageal sphincter.
Routine high resolution solid state manometry is a standard routine technique is currently performed in awake patients sitting upright voluntarily requested to swallow small boluses of liquid.
The entire sequence of events is studied using high resolution solid state manometry.
研究の種類
介入
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Francisco、California、アメリカ、94143
- University of California, San Francisco
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patients between 18 and 70 years of age (ASA I or II).
- Already scheduled for endotracheal tube extubation.
- Willing and able to give informed consent in either English or Spanish.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients not meeting entry criteria above.
- Refusal to give informed consent.
- Coagulopathy (INR > 2 and/or platelet count < 100,000.
- White Blood Cell count < 5,000/mm3
- Arrhythmia
- Serum creatinine > 2 mg/dl
- Prior known or suspected nasal obstruction.
- Known or suspected Zenker's diverticulum of esophagus, esophageal stricture, head/neck radiation therapy, hereditary telangiectasis, esophageal varices, cirrhosis.
- Anticoagulant usage such as heparin or Plavix
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:Manometry Device
At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.
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The use of esophageal manometry device during removal of endotracheal tube by anesthesia
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):
時間枠:The change in Basal Pressures will be recorded at the end of procedure.
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High-resolution manometry (HRM) determination of return of cricopharyngeal function - Basal Pressures: Upper esophageal sphincter (mmHg) - normal (34-104) |
The change in Basal Pressures will be recorded at the end of procedure.
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The Residual Pressures of patients during High-Resolution Motility/Manometry (HRM):
時間枠:The change in Residual Pressures will be recorded at the end of procedure.
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- Residual Pressures: Upper esophageal sphincter (mmHg) - normal (<12.0)
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The change in Residual Pressures will be recorded at the end of procedure.
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The Wave Duration of patients during High-Resolution Motility/Manometry (HRM):
時間枠:The change in Wave Duration will be recorded at the end of procedure.
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- Motility: Wave Duration (seconds) - normal (2.7-5.4)
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The change in Wave Duration will be recorded at the end of procedure.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of patients agreeing to study versus refusing study.
時間枠:During enrollment
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Percentage/number of patients/next of kin accepting protocol
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During enrollment
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Number of patients completing study.
時間枠:At the completion of procedure
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Percentage/number of patients completing esophageal motility/manometry study.
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At the completion of procedure
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Duration of HRM
時間枠:The HRM study of the cricopharyngeus will be measured for the 5 minute time period just before planned endotracheal extubation to the time during extubation and for the 5 minute period just after endotracheal extubation.
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Duration (minutes) of motility/manometry research study during withdrawal of endotracheal intubation.
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The HRM study of the cricopharyngeus will be measured for the 5 minute time period just before planned endotracheal extubation to the time during extubation and for the 5 minute period just after endotracheal extubation.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Stanley J Rogers, MD、University of California, San Francisco
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2025年7月1日
一次修了 (推定)
2027年6月30日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2022年4月21日
QC基準を満たした最初の提出物
2022年10月6日
最初の投稿 (実際)
2022年10月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。