EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE... | NCT05163379

Studies
EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS

NCT05163379

Sponsor

Okan University

Status

Unknown status

Last Update Posted

Dec 20, 2021Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Intensive Care Unit Acquired Weakness
Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern

Interventions

MOBILIZATION

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2021Estimated

Primary Completion Date

Feb 1, 2022Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Dec 6, 2021

First Submission Date that Met QC Criteria

Dec 6, 2021

First Posted Date

Dec 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2021

Last Update Posted Date

Dec 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Label	Type	Description	Intervention Names
INTENSIVE CARE PATIENTS		EARLY MOBILIZATION OF INTUBE PATIENTS	Other: MOBILIZATION

Name	Type	Description	Arm Group Labels	Other Names
MOBILIZATION	Other	EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION	INTENSIVE CARE PATIENTS

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

INTUBE PATIENTS IN ICU

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Gürkan ÇAMOK		Istanbul	İ̇stanbul	34959	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27307746	Background	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.