Timing of Mobilization on Delirium in Patients After Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Patients After Cardiac Surgery
• Interventions: Other: usual treatment; Other: Early Rehabilitation

• Registration Number: NCT06069349
• Lead Sponsor: Jingyuan,Xu

Brief Summary

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

Detailed Description

The prevalence of cardiac diseases is high, as the standard treatment for many heart diseases, a bunch of strategies are performed to improve the outcome of cardiac surgery.

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

Study Timeline

• Study First Submitted: 2023-09-01
• Study Start: 2023-09-15
• Study First Submitted QC: 2023-09-29
• Status Verified: 2023-10
• Study First Posted: 2023-10-05
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. > 18-year-old postoperative cardiac patient admitted to ICU, the time < 24h
• 2. Patients agree to participate in clinical research and sign informed consent before the start of the study

Exclusion Criteria

Patients who meet any of the following criteria are not eligible for inclusion in this study:

• 1. Pregnant and lactating women
• 2. There are contraindications to getting out of bed：
• 2.1 Low cardiac output syndrome
• (1) Application of IABP or PCPS (percutaneous cardiopulmonary support)
• (2) High doses of vasoactive drugs (norepinephrine> 0.5ug/kg.min)
• (3) SBP<=80mmHg
• (4) Acrocyanosis, wet and cold
• (5) Metabolic acidosis
• (6) Urine output less than 0.5ml/kg.h for more than 2 hours
• 2.2 Heart rate greater than or equal to 120 beats per minute at rest
• 2.3 Orthostatic hypotension (systolic blood pressure less than 80 mmHg after postural change)
• 2.4 Presence of arrhythmias leading to a drop in blood pressure (e.g., decreased blood pressure due to new-onset atrial fibrillation)
• 2.5 Difficulty breathing at rest or respiratory rate greater than 30 breaths per minute
• 2.6 Postoperative bleeding (200ml in 2-3 hours)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual treatment	usual treatment	-
Early mobilization	Early Rehabilitation	early mobilization in the ICU

Primary Outcome Measures

Name	Time	Method
duration of delirum	7 days	The duration of delirum in hours

Secondary Outcome Measures

Name	Time	Method
hospital length of stay	hospital length of stay, approximately 10 days	hospital length of stay, approximately 10 days

Trial Locations

Locations (1)

Zhongda hospital; 🇨🇳 Nanjing, Jiangsu, China