Early MobilizationNCT06344468
The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU
A study testing Early Mobilization in people with Early Mobilization and Sleep Quality, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU). The hypothesis are: Hypothesis I: Early mobilization positively affects the sleep quality of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Mobilization, Sleep Quality, Critical Care
- What is being tested?
- Early Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2023to 4 Mar 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older,
- Have been in the ICU for at least 36 hours,
- Be independent in their mobility activities,
- Maintain respiratory activity without being dependent on a device/equipment,
- Have a Glasgow Coma Scale score of at least 15,
- Have sedation discontinued within the first 6 hours.
Who cannot join
- Be fully sedated,
- Have neurological or orthopedic conditions that could create contraindications (such as cerebrovascular events, circulatory disorders, pulmonary embolism),
- Be unable to tolerate mobilization (severe bradycardia, arrhythmia, chest pain, hypotension, hypertension, tachypnea, SaO2 <90%, etc.),
- Have a Glasgow Coma Scale score below 15,
- Be dependent on mobility activities before surgery,
- Use sleep medication and experience sleep problems before surgery,
- Have extubation not performed within the first 24 hours after surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine
Istanbul
About this study
Official title: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU: A Randomized Controlled Study
The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).
The hypothesis are:
Read more
Hypothesis I: Early mobilization positively affects the sleep quality of patients.
Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).
Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).
Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure>160 mmHg), or hypotension (systolic pressure<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.
Control Group:
After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded.
- Conditions
- Early Mobilization, Sleep Quality, Critical Care, Nursing Caries
- Being tested
- Early Mobilization
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilizationOther
Essentially, early mobilization practices consist of two parts: in-bed and out-of-bed. In-bed mobilization; Active-passive joint range of motion (ROM) Exercises include raising the head in bed, turning in bed, in-bed exercises and sitting at the end of the bed. Out-of-bed mobilization includes the process of transferring from bed to chair, standing up, and returning to bed after standing up. In studies conducted on cardiac surgery, the early mobilization period is the first 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Early mobilization began after discontinuation of sedation and resolution of its effects within the first 12 hours. During early mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated and recorded in the supine and semi-fowler positions for in-bed mobilization assessment. For out-of-bed mobilization, physiological parameters were determined and recorded while the patient was in a sitting position, with the head elevated at 45° before mobilization.
With the assistance of a nurse, the patient was guided to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. Similar procedures were repeated during patient mobilization at 24 and 36 hours. Receives: Other: Early Mobilization |
| Control Group | No intervention | They underwent routine/standard postoperative mobilization procedures. Accordingly, patients were mobilized within the first 24 hours post-surgery, and during in-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated in the supine and semi-fowler positions.During out-of-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were determined. Respiratory parameters were frequently evaluated at intervals of up to 4 hours using arterial blood gas analysis. The patient was assisted by a nurse to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. These data were then evaluated internally. Similar procedures were repeated during patient mobilization at 24 and 36 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of stay of patients in the intensive care unit
The length of stay of a patient in the intensive care unit refers to the duration from the patient's admission to the intensive care unit until their discharge
Measured: At least 2 days, up to 12 months.
Secondary outcomes (4)
The Richards-Campbell Sleep Questionnaire (RCSQ)
The Richards Campbell Sleep Scale, developed by Kathy C. Richards in 1987, aims to determine patients' nighttime sleep depth, sleep onset latency, wakefulness during the night, time awake after sleep onset, and overall sleep quality. The scale consists of 6 items, with participants asked to rate each item on a scale from 0 to 100. Scores ranging from 0 to 25 indicate very poor sleep, while scores between 75 and 100 indicate very good sleep. As the total score on the scale increases, sleep quality also improves.
Measured: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU and at the 36th hour in the ICU.
The Glasgow Coma Scale (GCS)
The Glasgow Coma Scale (GCS) was developed by Teasdale and Jennett in 1974. GCS is one of the assessment tools used to define, classify, and eliminate the risk of incomplete or incorrect evaluation of levels of consciousness. With GCS, patients' eye opening, verbal, and motor responses are assessed. The total score on the scale is 15, with 15 points indicating full alertness and awareness. The lowest score on the scale is 3, indicating deep coma. According to GCS, a score of 8 or below indicates that the patient is unconscious and in a coma, requiring intensive care.
Measured: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU, and at the 36th hour in the ICU.
Physiological Parameter - for the experimental group
Researchers have developed a physiological parameter monitoring form to track and record patients' physiological parameters before and after surgery. The form includes minute respiratory rate, sPO2, PaO2, PaCO2, heart rate, blood pressure, body temperature, and pain values. The patient's minute respiratory rate, sPO2, heart rate, blood pressure, and body temperature will be monitored using monitoring devices. PaO2 and PaCO2 values will be monitored during the patient's intensive care process using arterial blood gas analysis. The patient's pain intensity will be evaluated using a Visual Analog Scale (VAS) ranging from 0 for no pain to 10 for severe pain.
Measured: At the moment of extubation, during the first mobilization within the first 12 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care.
Physiological Parameter - for the control group
Researchers have developed a physiological parameter monitoring form to track and record patients' physiological parameters before and after surgery. The form includes minute respiratory rate, sPO2, PaO2, PaCO2, heart rate, blood pressure, body temperature, and pain values. The patient's minute respiratory rate, sPO2, heart rate, blood pressure, and body temperature will be monitored using monitoring devices. PaO2 and PaCO2 values will be monitored during the patient's intensive care process using arterial blood gas analysis. The patient's pain intensity will be evaluated using a Visual Analog Scale (VAS) ranging from 0 for no pain to 10 for severe pain.
Measured: At the moment of extubation, during the first mobilization within the first 12-24 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start12 Apr 2023
- Primary completion5 Jun 2023
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early MobilizationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Sen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344468
- Sponsor's protocol ID
- 531393
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashkenazy S, DeKeyser-Ganz F. Assessment of the reliability and validity of the Comfort Scale for adult intensive care patients. Heart Lung. 2011 May-Jun;40(3):e44-51. doi: 10.1016/j.hrtlng.2009.12.011. Epub 2010 Apr 8.
PubMed 20561865Taito S, Shime N, Ota K, Yasuda H. Early mobilization of mechanically ventilated patients in the intensive care unit. J Intensive Care. 2016 Jul 29;4:50. doi: 10.1186/s40560-016-0179-7. eCollection 2016.
PubMed 27478617Chen B, You X, Lin Y, Dong D, Xie X, Zheng X, Li D, Lin W. A systematic review and meta-analysis of the effects of early mobilization therapy in patients after cardiac surgery: A protocol for systematic review. Medicine (Baltimore). 2020 Jan;99(4):e18843. doi: 10.1097/MD.0000000000018843.
PubMed 31977881TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.
PubMed 36286256Menges D, Seiler B, Tomonaga Y, Schwenkglenks M, Puhan MA, Yebyo HG. Systematic early versus late mobilization or standard early mobilization in mechanically ventilated adult ICU patients: systematic review and meta-analysis. Crit Care. 2021 Jan 6;25(1):16. doi: 10.1186/s13054-020-03446-9.
PubMed 33407707Norimoto M, Yamashita M, Yamaoka A, Yamashita K, Abe K, Eguchi Y, Furuya T, Orita S, Inage K, Shiga Y, Maki S, Umimura T, Sato T, Sato M, Enomoto K, Takaoka H, Hozumi T, Mizuki N, Kim G, Ohtori S. Early mobilization reduces the medical care cost and the risk of disuse syndrome in patients with acute osteoporotic vertebral fractures. J Clin Neurosci. 2021 Nov;93:155-159. doi: 10.1016/j.jocn.2021.09.011. Epub 2021 Sep 20.
PubMed 34656240Rezvani H, Esmaeili M, Maroufizadeh S, Rahimi B. The Effect of Early Mobilization on Respiratory Parameters of Mechanically Ventilated Patients With Respiratory Failure. Crit Care Nurs Q. 2022 Jan-Mar 01;45(1):74-82. doi: 10.1097/CNQ.0000000000000390.
PubMed 34818300
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06344468
- Acronym / sponsor ID
- 531393
- Conditions
- Early Mobilization, Sleep Quality, Critical Care, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 3 Apr 2024 (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 goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).
The hypothesis are:
Hypothesis I: Early mobilization positively affects the sleep quality of patients.
Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).
Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).
Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure>160 mmHg), or hypotension (systolic pressure<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.
Control Group:
After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Early MobilizationEarly mobilization began after discontinuation of sedation and resolution of its effects within the first 12 hours. During early mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated and recorded in the supine and semi-fowler positions for in-bed mobilization assessment. For out-of-bed mobilization, physiological parameters were determined and recorded while the patient was in a sitting position, with the head elevated at 45° before mobilization. With the assistance of a nurse, the patient was guided to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. Similar procedures were repeated during patient mobilization at 24 and 36 hours. |
| Control Group | No intervention | –They underwent routine/standard postoperative mobilization procedures. Accordingly, patients were mobilized within the first 24 hours post-surgery, and during in-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were evaluated in the supine and semi-fowler positions.During out-of-bed mobilization, physiological parameters (respiratory rate, SpO2, heart rate, blood pressure, body temperature, pain) were determined. Respiratory parameters were frequently evaluated at intervals of up to 4 hours using arterial blood gas analysis. The patient was assisted by a nurse to sit on the edge of the bed, stand up with support, sit on a chair next to the bed, and record respiratory rate, SpO2, heart rate, blood pressure, body temperature, and pain levels at 1, 5, and 10 minutes while sitting on the chair. These data were then evaluated internally. Similar procedures were repeated during patient mobilization at 24 and 36 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older,
- Have been in the ICU for at least 36 hours,
- Be independent in their mobility activities,
- Maintain respiratory activity without being dependent on a device/equipment,
- Have a Glasgow Coma Scale score of at least 15,
Key exclusion criteria (7 listed)
- Be fully sedated,
- Have neurological or orthopedic conditions that could create contraindications (such as cerebrovascular events, circulatory disorders, pulmonary embolism),
- Be unable to tolerate mobilization (severe bradycardia, arrhythmia, chest pain, hypotension, hypertension, tachypnea, SaO2 <90%, etc.),
- Have a Glasgow Coma Scale score below 15,
- Be dependent on mobility activities before surgery,
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 |
|---|---|---|
| Early MobilizationEssentially, early mobilization practices consist of two parts: in-bed and out-of-bed. In-bed mobilization; Active-passive joint range of motion (ROM) Exercises include raising the head in bed, turning in bed, in-bed exercises and sitting at the end of the bed. Out-of-bed mobilization includes the process of transferring from bed to chair, standing up, and returning to bed after standing up. In studies conducted on cardiac surgery, the early mobilization period is the first 12 hours. | Other | Experimental Group |
Primary outcome
The length of stay of patients in the intensive care unit
Time frame: At least 2 days, up to 12 months.
The length of stay of a patient in the intensive care unit refers to the duration from the patient's admission to the intensive care unit until their discharge
4 secondary outcomes
The Richards-Campbell Sleep Questionnaire (RCSQ)
Time frame: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU and at the 36th hour in the ICU.
The Glasgow Coma Scale (GCS)
Time frame: At the moment the patient is admitted to the hospital, at the 12th hour in the Intensive Care Unit (ICU), at the 24th hour in the ICU, and at the 36th hour in the ICU.
Physiological Parameter - for the experimental group
Time frame: At the moment of extubation, during the first mobilization within the first 12 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care.
Physiological Parameter - for the control group
Time frame: At the moment of extubation, during the first mobilization within the first 12-24 hours after surgery, 15, 30, and 60 minutes after mobilization, and at the 12th and 24th hours in intensive care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Results publication: PubMed 20561865Ashkenazy S, DeKeyser-Ganz F. Assessment of the reliability and validity of the Comfort Scale for adult intensive care patients. Heart Lung. 2011 May-Jun;40(3):e44-51. doi: 10.1016/j.hrtlng.2009.12.011. Epub 2010 Apr 8.
- Results publication: PubMed 27478617Taito S, Shime N, Ota K, Yasuda H. Early mobilization of mechanically ventilated patients in the intensive care unit. J Intensive Care. 2016 Jul 29;4:50. doi: 10.1186/s40560-016-0179-7. eCollection 2016.
- Results publication: PubMed 31977881Chen B, You X, Lin Y, Dong D, Xie X, Zheng X, Li D, Lin W. A systematic review and meta-analysis of the effects of early mobilization therapy in patients after cardiac surgery: A protocol for systematic review. Medicine (Baltimore). 2020 Jan;99(4):e18843. doi: 10.1097/MD.0000000000018843.
- Results publication: PubMed 36286256TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.
- Results publication: PubMed 33407707Menges D, Seiler B, Tomonaga Y, Schwenkglenks M, Puhan MA, Yebyo HG. Systematic early versus late mobilization or standard early mobilization in mechanically ventilated adult ICU patients: systematic review and meta-analysis. Crit Care. 2021 Jan 6;25(1):16. doi: 10.1186/s13054-020-03446-9.
- Results publication: PubMed 34656240Norimoto M, Yamashita M, Yamaoka A, Yamashita K, Abe K, Eguchi Y, Furuya T, Orita S, Inage K, Shiga Y, Maki S, Umimura T, Sato T, Sato M, Enomoto K, Takaoka H, Hozumi T, Mizuki N, Kim G, Ohtori S. Early mobilization reduces the medical care cost and the risk of disuse syndrome in patients with acute osteoporotic vertebral fractures. J Clin Neurosci. 2021 Nov;93:155-159. doi: 10.1016/j.jocn.2021.09.011. Epub 2021 Sep 20.
- Results publication: PubMed 34818300Rezvani H, Esmaeili M, Maroufizadeh S, Rahimi B. The Effect of Early Mobilization on Respiratory Parameters of Mechanically Ventilated Patients With Respiratory Failure. Crit Care Nurs Q. 2022 Jan-Mar 01;45(1):74-82. doi: 10.1097/CNQ.0000000000000390.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Mobilization in people with Early Mobilization and Sleep Quality, run by Istanbul University - Cerrahpasa 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 3 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of stay of patients in the intensive care unit (time frame: At least 2 days, up to 12 months.). 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 NCT06344468, which also lists 7 linked publications.
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 3 Apr 2024.