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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05163379
Other study ID # GURKANCAMOK
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 10, 2021
Est. completion date March 1, 2022

Study information

Verified date December 2021
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The present study was carried out as a quasi-experimental study in order to examine the effects of early mobilization of intubated patients in the intensive care unit and the effects of early mobilization on respiratory pattern and patient hemodynamics. The sample of the study consisted of 25 intubated patients monitored in the intensive care unit at in a private hospital between May 2020 and July 2021. Ethics committee approval and study permission were obtained from the hospital before starting the data collection process. Research data, descriptive data collection form, Richmond- Agitation Sedation Scale (RASS) scale, Muscle Strength Testing (Oxford Scale) and with the mobilization of the patients 45 minute in 30-60 minute including the preparation process, (1st Stage Semi Fowler position, 2nd Stage bedside sitting position, 3rd Stage in the bedside sitting position after mobilization) were registered in the Early Mobilization Follow-up Form and collected. Number and percentage calculations, repeated measurement ANOVA and Post Hoc Sheffe, LSD test analyzes were utilized in the evaluation of the data.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date March 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 18 years and over, - Hemodiamic stability (OCD >60, OCD <120, respiratory rate <35, SpO2 >90), - Areas of >3/5 (Oxford scale) and above on the lower limbs with areas of secure support, - The patient scores 0 (awake and calm) on the Richmond Agitation Sedation Scale (RASS), - PaO2 / FiO2 =300, - Body temperature below 38 degrees, - Platelet count =20,000 cells / mm3, - Having blood sugar of 60-360 mg/dl, - Having arterial monitoring, - Patient with 30% FiO2 due to mechanical ventilator, - Those with mechanical ventilator-dependent ventilation method (mode) PASB, - Patient with a PEEP value of 5 due to mechanical ventilator, - Patient with a PASB value of 10 connected to a mechanical ventilator, - A sample accepted by the patient who voluntarily agreed to participate in the study was approximated from the patient. Exclusion Criteria: - Patients under the age of 18, - Those with hemodynamic instability (OCD <60 mmHg, OCD >120 mmHg, breath rate >35, SpO2 <90), - Those who do not have secure unsupported sitting balance and have a score of >3/5 (Oxford scale) in the lower limbs, - Patients whose Richmond agitation sedation scale (RASS) is between +1 and +4 points, and patients with a score between -1 and -5, - Those with arrhythmia, - Patients without arterial monitoring, - Patients whose FiO2 percentage is not 30% in patients on mechanical ventilator, - Patients who do not have ventilation method (mod) PASB in patients on mechanical ventilator, - Patients who do not have a PEEP value of 5 in patients on mechanical ventilators, - Patients who do not have a PASB value of 10 in patients on mechanical ventilators, - Those with neurological and orthopedic contraindications, - Patients who could not get approval from the relatives of the patients who did not accept to participate in the study were excluded from the study.

Study Design


Related Conditions & MeSH terms

  • Intensive Care Unit Acquired Weakness

Intervention

Other:
MOBILIZATION
EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION

Locations

Country Name City State
Turkey Gürkan ÇAMOK Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Green M, Marzano V, Leditschke IA, Mitchell I, Bissett B. Mobilization of intensive care patients: a multidisciplinary practical guide for clinicians. J Multidiscip Healthc. 2016 May 25;9:247-56. doi: 10.2147/JMDH.S99811. eCollection 2016. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS HEMODYNAMIC EFFECTSRESPIRATORY PATTERN, BLOOD GAS ANALYSISZ ONE DAY
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