Clinical trial NCT06344468: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU
Official title: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Mobilization
Sleep Quality
Critical Care
Nursing Caries
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).

The hypothesis are:

Hypothesis I: Early mobilization positively affects the sleep quality of patients.

Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).

Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).

Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure\>160 mmHg), or hypotension (systolic pressure\<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.

Control Group:

After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded.


Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older,
* Have been in the ICU for at least 36 hours,
* Be independent in their mobility activities,
* Maintain respiratory activity without being dependent on a device/equipment,
* Have a Glasgow Coma Scale score of at least 15,
* Have sedation discontinued within the first 6 hours.

Exclusion Criteria:

* Be fully sedated,
* Have neurological or orthopedic conditions that could create contraindications (such as cerebrovascular events, circulatory disorders, pulmonary embolism),
* Be unable to tolerate mobilization (severe bradycardia, arrhythmia, chest pain, hypotension, hypertension, tachypnea, SaO2 \<90%, etc.),
* Have a Glasgow Coma Scale score below 15,
* Be dependent on mobility activities before surgery,
* Use sleep medication and experience sleep problems before surgery,
* Have extubation not performed within the first 24 hours after surgery.

Primary outcomes:
measure: The length of stay of patients in the intensive care unit
timeFrame: At least 2 days, up to 12 months.
Secondary outcomes:
measure: The Richards-Campbell Sleep Questionnaire (RCSQ)
timeFrame: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU and at the 36th hour in the ICU.
measure: The Glasgow Coma Scale (GCS)
timeFrame: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU, and at the 36th hour in the ICU.
measure: Physiological Parameter - for the experimental group
timeFrame: At the moment of extubation, during the first mobilization within the first 12 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care.
measure: Physiological Parameter - for the control group
timeFrame: At the moment of extubation, during the first mobilization within the first 12-24 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
Study officials:
References:
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