Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis (PTMVP)
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|ClinicalTrials.gov Identifier: NCT03406494|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Other: Early multicomponent physical therapy program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, multicenter, assessor-blinded, randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor will be independent from the study and blinded from patient allocations.|
|Official Title:||Southern Medical University Clinical Research Project Initiative：Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: intervention group
Early multicomponent physical therapy program plus sepsis standard therapy
Other: Early multicomponent physical therapy program
No Intervention: control group
Sepsis standard therapy, including early initiation of intravenous antibiotics, infection source debriding, appropriate fluid therapy, minimum sedation, protocolized weaning procedure, blood glucose control and early enteral feeding, etc.
- ICU 28-day mortality [ Time Frame: Through 28-day study period in the ICU. ]Sepsis or non-sepsis related death, undetermined cause of death.
- Incidence of ICU-required weakness [ Time Frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month. ]Using the Medical Research Council (MRC) Score for Muscle Strength to test 12 muscle groups in upper extremities (wrist flexion, elbow flexion, shoulder abduction) and lower extremities (dorsiflexion, knee extension, hip flexion). The MRC sum score ranges from 0 (complete paralysis) to 60 (full strength) as determined by manual muscle testing (MMT), which grades muscle strength from 0 (paralysis) to 5 (normal muscle strength) in each muscle group tested. Patient with a MRC sum score of < 48 or a mean MRC score of < 4 per muscle group will be considered to have ICUAW. If measurement is impossible at recruitment, patient will be deemed as without ICUAW by a Barthel Index score > 60, which ranges from 0 (complete dependence) to 100 (complete independence), collected from a proxy reflecting baseline independent functional status 2 weeks prior to critical illness.
- Incidence of delirium [ Time Frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month. ]Acute cerebral dysfunction with altered mental status, inattention, and either disordered thinking or an altered level of consciousness as determined by the Confusion Assessment Method for the ICU (CAM-ICU). If assessment is impossible at recruitment, patient will be considered without delirium by absence of a history of insanity collected from a proxy reflecting baseline mental status 2 weeks prior to critical illness.
- Incidence of diaphragmatic dysfunction [ Time Frame: Assessed on the day of first try to wean from ventilator, repeated on the days of ICU discharge and hospital discharge, with an average of 1 month. ]Maximum negative inspiratory pressure (PImax) less than - 80 cm H2O is usually considered to have clinically important inspiratory muscle weakness. Measurements will be performed by using inspiratory hold key on ventilator (intubated patient) or a one-way exhalation valve placed on the opening of mouth (extubated patient). Patient will be instructed to perform maximal inspiratory efforts for 20 seconds against occluded airway at functional residual lung volume (FRC), and change in pressure be recorded by an external data acquisition system (Powerlab/16sp ML795, Australia ADInstruments) through a physiological pressure sensor (MLT 844, Australia ADInstruments) connected to the opening of endotracheal tube or the valve. The signal sampling frequency will be set at 100 Hz and low-pass filtering frequency at 20 Hz. The signal collected will be digitalized and analyzed in a manner of time-domain, and the PImax be recorded after 3 repetitions.
- Incidence of acute gastrointestinal injury [ Time Frame: Assessed on the day of recruitment, repeated on the days of first try to wean from ventilator, ICU discharge and hospital discharge, with an average of 1 month. ]Malfunctioning of the GI tract in critically ill patients due to their acute illness, distinguished and graded by severity of GI symptoms (e.g., feeding intolerance, vomiting, diarrhoea, paralysis, high gastric residual volumes (HGRVs). Acute gastrointestinal injury (AGI) grade I: increased risk to develop GI dysfunction or failure; AGI grade II: GI dysfunction (interventions required); AGI grade III: GI failure (GI function cannot be restored with interventions); AGI grade IV: dramatically manifesting GI failure.
- Ventilator dependence [ Time Frame: Number of days required to weaning after the first try, number of days on ventilator, assessed within an average of 3 weeks. ]Referred to one of the following categories: difficult weaning: fail initial weaning and require up to 3 spontaneous breath test (SBT) or ≤7 days to achieve success; delayed weaning: fail at least 3 weaning attempts or require > 7 days to weaning after the first SBT; prolonged mechanical ventilation (PMV): requiring ventilator support for more than 21 days.
- Adverse events [ Time Frame: Through physical therapy periods, an average of 1 month. ]Unexpected physiologic response or patient complaints to physical exercise, e.g., more than 20% variability in rest heart rate; 110 mmHg < mean arterial pressure < 60 mmHg; decremental pulse oximetry < 90%; severe dyspnea as determined by the Modified Borg Dyspnea Scale > 4 (ranged from 0-10, indicative of dyspnea degree from just noticeable to maximum); patient-ventilator asynchrony; altered mentation; catheters or tubes displacement; documented organ damage; accidental death.
- Length of stay [ Time Frame: From admission to ICU discharge and hospital discharge, estimated between 4 to 6 weeks. ]Number of days spent in the ICU or hospital.
- Independent functional status [ Time Frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge. ]Referred to ability to perform 10 activities of daily living (ADL's), including eating, transfer from bed to chair, dressing, toileting, bathing, grooming, walking, stair climbing, maintaining continence. Independent functional status is determined by a Barthel Index Score > 60, which ranged from 0 (complete dependence) to 100 (complete independence).
- Health-related quality of life (HRQOL) [ Time Frame: The 3rd, 6th and 12th months of 1-year follow up after hospital discharge. ]Evaluated by using the mandarin version Short-Form-36 Questionnaire translated by the Zhejiang University, China., consisting of eight domains (e.g., physical function (PF), role limitations due to physical problems (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role limitations due to emotional problems (RE), mental health (MH). The combined score for each domain is obtained by summing score of each item contained in the domain and directly converted into a 0-100 score scale using the Likert method of summated ratings. A score scale of zero is equivalent to maximum disability and 100 equals to the best possible health state.
- One-year mortality [ Time Frame: One year. ]All-cause death during 1-year follow-up after hospital discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406494
|Contact: Hua Wang||+86 firstname.lastname@example.org|
|Study Director:||Yan Zhang||Zhujiang Hospital|