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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Thang Toan Nguyen, PhD
- Telefonszám: +084916874795
- E-mail: nguyentoanthang@hmu.edu.vn
Tanulmányi helyek
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Hanoi, Vietnam
- Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital
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Kapcsolatba lépni:
- Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.
- Telefonszám: +084869587720
- E-mail: trungtamgaymehoisuc@bachmai.edu.vn
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
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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.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Number of Participants With Clinically Relevant Hypotension
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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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.
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Number of Participants With Clinically Relevant Hypoxemia
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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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:
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Number of participants with Severe hypotension
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Number of participants with Severe hypotension, Severe hypotension is defined as mean arterial pressure <60 mmHg or systolic blood pressure <80 mmHg.
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Number of participants with severe hypoxemia
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Number of participants with severe hypoxemia.
Severe hypoxemia is defined as any oxygen saturation <85%.
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Number of Participants Requiring Airway Intervention
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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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.
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Vasopressor use
Időkeret: From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Administration of vasopressor medication to treat peri-procedural hypotension.
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From first propofol administration to discharge from the recovery area, assessed up to 60 minutes.
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Time to Discharge From the Recovery Area
Időkeret: From end of procedure to discharge from the recovery area, assessed up to 4 hours.
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Time from end of procedure to discharge from the recovery area.
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From end of procedure to discharge from the recovery area, assessed up to 4 hours.
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- BMH-GI-PROPOFOL-OBS-2026-01
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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