Corrélation entre l'hypotension postprandiale et l'hypotension post-induction chez les personnes âgées.
Corrélation entre l'hypotension postprandiale et les événements indésirables périopératoires tels que l'hypotension post-induction chez les personnes âgées : une étude observationnelle prospective.
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Chine, 100730
- Peking Union Medical College Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital
La description
Inclusion Criteria:
- Elderly patients (≥ 65 years old）;
- Patients with American Society of Anesthesiologists(ASA) grade I-III;
- Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
- Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
Exclusion Criteria:
- Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
- Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
- Patients with chronic kidney disease requiring dietary restrictions or dialysis.
- Patients with Parkinson's disease or other conditions causing tremors.
- Patients with problems related to oral food ingestion or those requiring enteral nutrition.
- Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
- Patients unable to remain in a supine position for at least 2 hours.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Postprandial hypotension group
Patients who have a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of the lunch |
|
No postprandial hypotension group
Patients who do not meet the postprandial hypotension criteria within 2 hours of the lunch |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-induction hypotension
Délai: Within 20 minutes after induction or before incision.
|
which is defined as systolic blood pressure (SBP) <90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision. |
Within 20 minutes after induction or before incision.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative complications
Délai: Within 30 days after surgery
|
We will use the Clavien-Dindo system to grade postoperative complications. |
Within 30 days after surgery
|
|
early intraoperative hypotension （eIOH）
Délai: within the first 30 minutes after the start of surgery
|
which is defined asa systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a decrease of more than 30% from baseline |
within the first 30 minutes after the start of surgery
|
|
mortality within 30 days after surgery
Délai: within 30 days after surgery
|
we will assess the mortality by postoperative follow-up |
within 30 days after surgery
|
|
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)
Délai: within 180 days after surgery
|
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be employed to evaluate postoperative functional health status. The 12-item version yields a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer health outcomes. |
within 180 days after surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Li Xu, M.D., Peking Union Medical College Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- I-22PJ008
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .