Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy (PRO-GI SAFE)
Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study
調査の概要
詳細な説明
Propofol is widely used for diagnostic gastrointestinal endoscopy because of its rapid onset and recovery profile, but it may be associated with cardiopulmonary adverse events, particularly hypotension and hypoxemia. The reported incidence of these events varies substantially across studies because of differences in patient populations, definitions, monitoring intensity, and sedation/anesthesia practice.
This single-center prospective cohort study will enroll adult patients undergoing diagnostic gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent. Eligible participants will be consecutively recruited at Bach Mai Hospital. Baseline demographic characteristics, comorbidities, airway assessment findings, obstructive sleep apnea risk, procedural characteristics, and sedation/anesthesia-related variables will be collected using a standardized case report form.
The two co-primary outcomes are clinically relevant hypotension and clinically relevant hypoxemia during the peri-procedural period. Participants will be monitored from pre-procedure baseline through the procedure and until discharge from the recovery area. If early post-procedure observation is prolonged because of a sedation/anesthesia-related event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.
Two separate multivariable logistic regression models will be developed to identify independent predictors of clinically relevant hypotension and clinically relevant hypoxemia. The study is intended to inform risk stratification and improve patient safety during propofol-based diagnostic gastrointestinal endoscopy
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Thang Toan Nguyen, PhD
- 電話番号：+084916874795
- メール：nguyentoanthang@hmu.edu.vn
研究場所
-
-
-
Hanoi、ベトナム
- Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
-
コンタクト：
- Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.
- 電話番号：+084869587720
- メール：trungtamgaymehoisuc@bachmai.edu.vn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18 years or older
- Scheduled for diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy
- Planned use of propofol as the primary sedative/anesthetic agent for diagnostic gastrointestinal endoscopy
- American Society of Anesthesiologists physical status I to III
- Able to provide informed consent or has legally authorized representative consent according to local regulations
Exclusion Criteria:
- Therapeutic or interventional gastrointestinal endoscopy, including ERCP, EUS-guided intervention, EMR, ESD, endoscopic hemostasis, or polypectomy
- Planned sedation/anesthesia without propofol as the primary sedative/anesthetic agent
- Known allergy or contraindication to propofol
- Pregnancy or suspected pregnancy
- Emergency condition requiring immediate advanced airway control before the procedure
- Inability to obtain essential baseline or outcome data required for the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Cohort Description
Adult patients undergoing diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy with propofol as the primary sedative/anesthetic agent at a tertiary referral hospital.
All enrolled participants will receive standard peri-procedural monitoring and will be followed from pre-sedation assessment through discharge from the recovery area.
If early post-procedure observation is prolonged because of a sedation-related cardiopulmonary event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.
|
Propofol is the primary sedative/anesthetic agent used for diagnostic gastrointestinal endoscopy according to routine clinical practice.
The loading dose, incremental bolus doses, maintenance infusion rate if used, total dose, weight-normalized total dose, timing of administration, and any adjunct sedative or analgesic medications will be recorded as observational exposure variables.
Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.
|
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 |
|---|---|---|
|
Number of Participants With Clinically Relevant Hypotension
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with clinically relevant hypotension during propofol-based diagnostic gastrointestinal endoscopy.
Clinically relevant hypotension should be defined according to the protocol-specified blood pressure threshold and duration.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of Participants With Clinically Relevant Hypoxemia
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with clinically relevant hypoxemia during propofol-based diagnostic gastrointestinal endoscopy. Clinically relevant hypoxemia should be defined according to the protocol-specified oxygen saturation threshold and duration. Clinically relevant hypoxemia is defined as at least one of the following during the peri-procedural period:
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with Severe hypotension
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with Severe hypotension, Severe hypotension is defined as mean arterial pressure <60 mmHg or systolic blood pressure <80 mmHg.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of participants with severe hypoxemia
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants with severe hypoxemia.
Severe hypoxemia is defined as any oxygen saturation <85%.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Number of Participants Requiring Airway Intervention
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Number of participants who require any airway intervention, including head repositioning, chin lift, jaw thrust, oral or nasal airway insertion, bag-mask ventilation, or tracheal intubation.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
|
Vasopressor use
時間枠：From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
Administration of vasopressor medication to treat peri-procedural hypotension.
|
From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Discharge From the Recovery Area
時間枠：From end of procedure to discharge from the recovery area, assessed up to 4 hours.
|
Time from end of procedure to discharge from the recovery area.
|
From end of procedure to discharge from the recovery area, assessed up to 4 hours.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BMH-GI-PROPOFOL-OBS-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。