- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05163379
EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS
December 6, 2021 updated by: Gürkan ÇAMOK, Okan University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İ̇stanbul
-
Istanbul, İ̇stanbul, Turkey, 34959
- Gürkan ÇAMOK
-
Contact:
- GÜRKAN ÇAMOK
- Phone Number: +905380301709
- Email: gurkancamok@yahoo.com.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
INTUBE PATIENTS IN ICU
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
INTENSIVE CARE PATIENTS
EARLY MOBILIZATION OF INTUBE PATIENTS
|
EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS
Time Frame: ONE DAY
|
HEMODYNAMIC EFFECTSRESPIRATORY PATTERN, BLOOD GAS ANALYSISZ
|
ONE DAY
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 10, 2021
Primary Completion (Anticipated)
February 1, 2022
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
December 6, 2021
First Submitted That Met QC Criteria
December 6, 2021
First Posted (Actual)
December 20, 2021
Study Record Updates
Last Update Posted (Actual)
December 20, 2021
Last Update Submitted That Met QC Criteria
December 6, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- GURKANCAMOK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
all of
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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