NCT05163379

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 6, 2021

Last Update Submit

December 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

INTENSIVE CARE PATIENTS

EARLY MOBILIZATION OF INTUBE PATIENTS

Other: MOBILIZATION

Interventions

EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION

INTENSIVE CARE PATIENTS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

INTUBE PATIENTS IN ICU

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gürkan ÇAMOK

Istanbul, İ̇stanbul, 34959, Turkey (Türkiye)

Location

Related 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.

    PMID: 27307746BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Graduate Student

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

December 10, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations