Timing of Mobilization on Delirium in Patients After Cardiac Surgery

The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study

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 Overview

• Status: Recruiting
• Conditions: Patients After Cardiac Surgery
• Intervention / Treatment: Other: usual treatment; Other: Early Rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyuan Xu, M.D.; Phone Number: 008613851417209; Email: 13851417209@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Zhongda Hospital
      • Contact: Jingyuan Xu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: usual treatment	Other: usual treatment; Patients are not allowed to exercise Early Rehabilitation
Experimental: Early mobilization; early mobilization in the ICU	Other: Early Rehabilitation; Early Rehabilitation for patients after cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of delirum	The duration of delirum in hours	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital length of stay	hospital length of stay, approximately 10 days	hospital length of stay, approximately 10 days

Collaborators and Investigators

• Sponsor: Jingyuan,Xu
• Investigators: Study Director: Jingyuan Xu, M.D., Study Principal Investigator Southeast University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2023ZDSYLL356-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No