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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34959

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
INTENSIVE CARE PATIENTS
EARLY MOBILIZATION OF INTUBE PATIENTS
Other: MOBILIZATION
EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Okan University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GURKANCAMOK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

all of

Study Data/Documents

  1. Study Protocol

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings