Intensive Care Unit Acquired WeaknessNCT05163379
EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern, run by Okan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern
- What is being tested?
- MOBILIZATION
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2021to 1 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: INTUBE PATIENTS IN ICU
Who may be able to join
- 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,
Show all 14Show fewer
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gürkan ÇAMOK
Istanbul, İ̇stanbul, 34959
GÜRKAN ÇAMOK, +905380301709, gurkancamok@yahoo.com.tr
About this study
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.
- Conditions
- Intensive Care Unit Acquired Weakness, Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern
- Being tested
- MOBILIZATION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOBILIZATIONOther
EARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION
| Study group | Role | What they receive |
|---|---|---|
| INTENSIVE CARE PATIENTS | EARLY MOBILIZATION OF INTUBE PATIENTS Receives: Other: MOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS
HEMODYNAMIC EFFECTSRESPIRATORY PATTERN, BLOOD GAS ANALYSISZ
Measured: ONE DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 Dec 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gürkan ÇAMOK, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163379
- Sponsor's protocol ID
- GURKANCAMOK
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all of
Publications
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.
PubMed 27307746
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS
- ClinicalTrials.gov ID
- NCT05163379
- Acronym / sponsor ID
- GURKANCAMOK
- Conditions
- Intensive Care Unit Acquired Weakness, Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INTENSIVE CARE PATIENTS | – | Other: MOBILIZATIONEARLY MOBILIZATION OF INTUBE PATIENTS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- INTUBE PATIENTS IN ICU
Key inclusion criteria (14 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOBILIZATIONEARLY MOBILIZATION OF INTUBE PATIENTS AND ITS EFFECTS OF MOBILIZATION | Other | INTENSIVE CARE PATIENTS |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Background: PubMed 27307746Green 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.
- Individual participant dataSharing planned: Undecided. all of
Related trials for Intensive Care Unit Acquired Weakness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Evidence-based, Customized, Motion-recognition Rehabilitation System Development for Bed-ridden Patients - Validation of Effectiveness: Rehabit: Swim
ICU-acquired Weakness
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS (time frame: ONE DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.