Timing of Mobilization on Delirium in Patients After Cardiac Surgery

Jingyuan,Xu

Status: Enrolling

Conditions: Patients After Cardiac Surgery

Treatments: Other: Early Rehabilitation; Other: usual treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06069349

2023ZDSYLL356-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

usual treatment

Placebo Comparator group

Treatment:

Other: usual treatment

Early mobilization

Experimental group

Description:

early mobilization in the ICU

Treatment:

Other: Early Rehabilitation