Continuous BP Monitoring During Sedation for Endoscopy
Continuous Noninvasive Blood Pressure Monitoring During Sedation for High-Risk Patients Undergoing Gastrointestinal Endoscopy
This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using to continuous noninvasive blood pressure measurement. The study is designed to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
This is a single-site observational, before/after cohort study comparing intermittent blood pressure measurement using an oscillometric arm cuff to continuous noninvasive blood pressure measurement on the incidence of hypotension in high-risk patients undergoing sedation for upper or lower endoscopic procedures.
The primary aim is to determine the impact of the use of continuous noninvasive blood pressure monitoring on the incidence of hypotension. The secondary aims are to evaluate the impact of continuous blood pressure monitoring on total IV fluid administered, total vasopressor administered, intra-operative depth of sedation, post-operative nausea and vomiting (PONV), and the time to discharge readiness.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Neal Fleming, MD, PhD
- Telefonnummer: 916 734-5028
- E-post: nwfleming@health.ucdavis.edu
Studera Kontakt Backup
- Namn: David Asseff, MD
- Telefonnummer: 916 734-5028
- E-post: dasseff@healt.ucdavis.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
High-Risk Patients Undergoing Gastrointestinal Endoscopy
Beskrivning
Inclusion Criteria:
- Age ≥ 50 years
- American Society of Anesthesiologists (ASA) Physical Status ≥ 3
- Scheduled for upper or lower endoscopic procedure with planned propofol administration
- Planned oscillometric blood pressure monitoring using arm cuff without an arterial pressure catheter.
Exclusion Criteria:
- Age <50 years
- ASA Physical Status 1 or 2
- Patients known to be pregnant
- Patients with an existing arterial pressure catheter
- Patients on mechanical circulatory support
- Patients with planned intubation for procedure
- Patients with a difference in systolic blood pressure measurement between right and left upper extremities > 10 mmHg
- Patients with extreme contraction of the smooth muscle in the arteries and arterioles of the arm and hand, such as may be present with Raynaud's disease
- Patients with an inability to place the noninvasive finger cuffs due to anatomy, skin condition, or obstructive paraphernalia (such as false nails)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
High-Risk Patients Undergoing Gastrointestinal Endoscopy
Patients scheduled for elective endoscopic procedures |
continuous noninvasive blood pressure monitoring |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
incidence of hypotension
Tidsram: during procedure and post-procedure recovery period
|
Mean Arterial Pressure (MAP) < 65 mmHg for a total duration ≥ 5 minutes |
during procedure and post-procedure recovery period
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
total IV fluid administered
Tidsram: during procedure and post-procedure recovery period
|
Volume in ml/kg/hr |
during procedure and post-procedure recovery period
|
|
total vasopressor administered
Tidsram: during procedure and post-procedure recovery period
|
Total doses in mg/kg |
during procedure and post-procedure recovery period
|
|
intra-operative depth of sedation
Tidsram: during procedure and post-procedure recovery period
|
Patient State Index (PSI), mean, min, max |
during procedure and post-procedure recovery period
|
|
post-operative nausea and vomiting
Tidsram: during procedure and post-procedure recovery period
|
Incidence requiring treatment |
during procedure and post-procedure recovery period
|
|
time to discharge readiness
Tidsram: during procedure and post-procedure recovery period
|
Time from Post-Anesthesia Care Unit (PACU) admission to Aldrete Score=10 |
during procedure and post-procedure recovery period
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Neal Fleming, MD, PhD, University of California, Davis
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2465371
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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