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The trial was stopped prematurely due to the COVID-19 pandemic
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| Name | Class |
|---|---|
| Hospital Ernesto Dornelles | OTHER |
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The present randomized crossover clinical trial aims to evaluate the influence of different body postures on pulmonary aeration among mechanically ventilated critically ill patients. Patients admitted to the intensive care unit receiving invasive mechanical ventilation >24 hours, and without contraindications to mobilization, will be randomly assigned to one of two sequences of interventions at a single day: arm 1: bedside sitting posture followed by orthostatic board at 45º and 60º; arm 2: orthostatic board at 45º, 60º and 80º followed by bedside sitting posture. Each postural protocol (bedside sitting posture protocol or orthostatic board posture protocol) will last 30 minutes. A washout window period between 1,5h and 2,5h will be applied between the two postural interventions. The primary outcome is the lung aeration assessed using the Lung Ultrasound Score (LUS) performed by trained evaluators at the end of postural protocol. Secondary outcomes include ventilatory mechanics (static compliance, airway resistance and respiratory work), PaO2/FiO2 ratio, Level of consciousness according to the Richmond Agitation-Sedation Scale (RASS), and adverse events (hypertension, hypotension, tachicardia, bradycardia, tachypnea, bradypnea, decreased level of consciousness, patient distress, fall to knees, invasive device traction or loss, filter hemodialysis clotting or disruption).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedside Sitting followed by Orthostatic Board | Other | Bedside sitting posture protocol followed by orthostatic board posture protocol. |
|
| Orthostatic Board followed by Bedside Sitting | Other | Orthostatic board posture protocol followed by bedside sitting posture protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthostatic board posture | Device | Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung Aeration Scores Post Intervention (Verticalization) | Evaluation of lung aeration using the Lung Ultrassound Score. The division landmark it is the anterior and posterior axillary lines, with each region being divided into upper and lower. Thus, six representative zones of each lung are assessed. Normal aeration is represented by the presence of pleural sliding and horizontal A lines, or by at least three vertical B lines, a 0 score is assigned. When a moderate loss of aeration takes place, characterized by multiple B lines, either regularly or irregularly spaced, originating from the pleural line, a score of 1 is assigned. When coalescent B lines are present in several intercostal spaces occupying the whole intercostal space, a score of 2 is assigned to the region. If there is a total loss of lung aeration, as observed in lung consolidation, a score of 3 is assigned. The total LUS score is achieved by summing the 12 regions examined, with its scores ranging from 0 to 36, and the higher the score, the worse lung aeration. | Single day assessment post intervention of the sitting posture (protocol lasts 30 minutes) and post intervention of the standing board (protocol lasts 30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal Volume | Variations in tidal volume according to body position. Tidal volume expresses the value (in ml) that enters and leaves the lungs at each respiratory cycle. Variations extracted directly from the mechanical ventilation monitor. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes). |
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Inclusion Criteria: 18 years or older; Invasive Mechanical Ventilation > 24 hours; no weaning expectation on screening day for study eligibility; Signature of Informed Consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Dal Lago | Experimental Physiology Laboratory - Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) | Study Director |
| Regis Gourlart Rosa | Intensive Care Unit, Hospital Moinhos de Vento | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ernesto Dornelles | Porto Alegre | Brazil | ||||
| Hospital Moinhos de Vento |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30327334 | Background | Sonpeayung R, Tantisuwat A, Klinsophon T, Thaveeratitham P. Which Body Position Is the Best for Chest Wall Motion in Healthy Adults? A Meta-Analysis. Respir Care. 2018 Nov;63(11):1439-1451. doi: 10.4187/respcare.06344. Epub 2018 Oct 16. | |
| 19234100 | Background | Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bedside Sitting (First Intervention) Followed by Orthostatic Board (Second Intervention) | Bedside sitting posture protocol followed by orthostatic board posture protocol. Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes. |
| FG001 | Orthostatic Board (First Intervention) Followed by Bedside Sitting (Second Intervention) | Orthostatic board posture protocol followed by bedside sitting posture protocol. Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Study participants were randomized to Bedside sitting (first intervention) posture protocol followed by orthostatic board (second intervention) posture protocol or Orthostatic board (first intervention) posture protocol followed by bedside sitting posture (second intervention) protocol. Orthostatic board posture: Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes Bedside sitting posture: Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lung Aeration Scores Post Intervention (Verticalization) | Evaluation of lung aeration using the Lung Ultrassound Score. The division landmark it is the anterior and posterior axillary lines, with each region being divided into upper and lower. Thus, six representative zones of each lung are assessed. Normal aeration is represented by the presence of pleural sliding and horizontal A lines, or by at least three vertical B lines, a 0 score is assigned. When a moderate loss of aeration takes place, characterized by multiple B lines, either regularly or irregularly spaced, originating from the pleural line, a score of 1 is assigned. When coalescent B lines are present in several intercostal spaces occupying the whole intercostal space, a score of 2 is assigned to the region. If there is a total loss of lung aeration, as observed in lung consolidation, a score of 3 is assigned. The total LUS score is achieved by summing the 12 regions examined, with its scores ranging from 0 to 36, and the higher the score, the worse lung aeration. | Posted | Mean | Standard Deviation | score on a scale | Single day assessment post intervention of the sitting posture (protocol lasts 30 minutes) and post intervention of the standing board (protocol lasts 30 minutes) |
The evaluations took place in a single moment/day. Possible adverse events were evaluated from randomization to the last assessment of the outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bedside Sitting | Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypontension | Cardiac disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PT Douglas Neves | Hospital Moinhos de Vento | (51) 9.98975514 | nevesfisioup@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 | Nov 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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at a single day: arm 1: bedside sitting posture followed by orthostatic board at 45º and 60º; arm 2: orthostatic board at 45º, 60º, and 80º followed by bedside sitting posture.
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| Bedside sitting posture | Other | Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes. |
|
| Minute Volume | Variations in minute volume according to body position. Minute volume expresses the value (in L/min) that enters and leaves the lungs during one minute. Variations extracted directly from the mechanical ventilation monitor. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes) |
| Number of Professionals for Verticalization | The absolute number of professionals required to perform each the chest verticalization protocols was counted. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes) |
| Porto Alegre |
| Brazil |
| 25215147 | Background | Dong ZH, Yu BX, Sun YB, Fang W, Li L. Effects of early rehabilitation therapy on patients with mechanical ventilation. World J Emerg Med. 2014;5(1):48-52. doi: 10.5847/wjem.j.issn.1920-8642.2014.01.008. |
| 25307087 | Background | Porto EF, Castro AA, Leite JR, Miranda SV, Lancauth A, Kumpel C. Comparative analysis of respiratory systems compliance in three different positioning (lateral, dorsal and sitting) in patients in prolonged invasive mechanical ventilation. Rev Bras Ter Intensiva. 2008 Sep;20(3):213-9. English, Portuguese. |
| 15605335 | Background | Chang AT, Boots RJ, Hodges PW, Thomas PJ, Paratz JD. Standing with the assistance of a tilt table improves minute ventilation in chronic critically ill patients. Arch Phys Med Rehabil. 2004 Dec;85(12):1972-6. doi: 10.1016/j.apmr.2004.03.024. |
| 26961919 | Background | Umei N, Atagi K, Okuno H, Usuke S, Otsuka Y, Ujiro A, Shimaoka H. Impact of mobilisation therapy on the haemodynamic and respiratory status of elderly intubated patients in an intensive care unit: A retrospective analysis. Intensive Crit Care Nurs. 2016 Aug;35:16-21. doi: 10.1016/j.iccn.2016.02.001. Epub 2016 Mar 5. |
| 20522353 | Background | Sustic A, Protic A, Cicvaric T, Zupan Z. The addition of a brief ultrasound examination to clinical assessment increases the ability to confirm placement of double-lumen endotracheal tubes. J Clin Anesth. 2010 Jun;22(4):246-9. doi: 10.1016/j.jclinane.2009.07.010. |
| 14695718 | Background | Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. doi: 10.1097/00000542-200401000-00006. |
| 19633538 | Background | Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb. |
| 17316468 | Background | Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. doi: 10.1186/cc5668. |
| 20851923 | Background | Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17. |
| 22584759 | Background | Soummer A, Perbet S, Brisson H, Arbelot C, Constantin JM, Lu Q, Rouby JJ; Lung Ultrasound Study Group. Ultrasound assessment of lung aeration loss during a successful weaning trial predicts postextubation distress*. Crit Care Med. 2012 Jul;40(7):2064-72. doi: 10.1097/CCM.0b013e31824e68ae. |
| 38265318 | Derived | Neves D, Marques Filho PR, Townsend RDS, Rodrigues CDS, Tagliari L, Madeira LC, Mattioni MF, Camillis MLF, Leaes CGS, Andrade JMS, Robinson CC, Sganzerla D, Drehmer L, Costa DFMD, Machado AS, Rosa RG, Lago PD. Impact of vertical positioning on lung aeration among mechanically ventilated intensive care unit patients: a randomized crossover clinical trial. Crit Care Sci. 2023 Oct-Dec;35(4):367-376. doi: 10.5935/2965-2774.20230069-en. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Charlson comorbidity index | One point was assigned to: past history of myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic lung disease, connective tissue disease, peptic ulcer disease, mild liver disease and diabetes. The comorbidities weighted with 2 points were: diabetes with target organ damage, hemiplegia, moderate to severe renal disease, malignant neoplasm, leukaemia and lymphoma. Moderate to severe liver disease was weighted with 3 points and metastatic solid tumour and AIDS (stage C) were weighted with 6 points. higher values = worse. Total score: summed | Mean | Standard Deviation | score |
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| Reason for mechanical ventilation | Count of Participants | Participants |
|
| Duration of Invasive Mechanical Ventilation | Mean | Standard Deviation | days |
|
| ICU admission type | Count of Participants | Participants |
|
| Simplified Acute Physiology Score 3 | The Simplified Acute Physiology Score 3 prognostic system is composed of 20 variables, represented by an acute physiological score and assessment of the previous state, aiming to establish a predictive index of mortality for patients admitted to intensive care units. The lowest value assigned by the score is 0 and the highest is 217 points, with higher values indicating greater severity. | Mean | Standard Deviation | score |
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| Continuous parenteral sedation | Count of Participants | Participants |
|
| Richmond Agitation-Sedation Scale | The Richmond Agitation-Sedation Scale assesses the level of sedation and agitation of a patient under critical care. Its score ranges from +4 to -5, with the highest value ( +4 ) being described as a combative and violent patient, and the lowest value (-5) described as a patient not responding to verbal or physical stimuli. | Mean | Standard Deviation | score |
|
| Mode of mechanical ventilation | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Bedside Sitting | Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes. |
| OG001 | Orthostatic Board | Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes |
|
|
| Secondary | Tidal Volume | Variations in tidal volume according to body position. Tidal volume expresses the value (in ml) that enters and leaves the lungs at each respiratory cycle. Variations extracted directly from the mechanical ventilation monitor. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Posted | Median | Inter-Quartile Range | ml | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes). |
|
|
|
| Secondary | Minute Volume | Variations in minute volume according to body position. Minute volume expresses the value (in L/min) that enters and leaves the lungs during one minute. Variations extracted directly from the mechanical ventilation monitor. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Posted | Median | Inter-Quartile Range | L/min | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes) |
|
|
|
| Secondary | Number of Professionals for Verticalization | The absolute number of professionals required to perform each the chest verticalization protocols was counted. Outcome has no range, neither higher or lower values are considered to be a better or worse outcome | Posted | Median | Inter-Quartile Range | professionals per procedure | Single day assessment at the end of sitting posture protocol (the protocol lasts 30 minutes) and at the end of orthostatic board protocol (the protocol lasts 30 minutes) |
|
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| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Orthostatic Board | Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes | 0 | 19 | 0 | 19 | 3 | 19 |
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
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