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| Name | Class |
|---|---|
| Universidade Federal de Pernambuco | OTHER |
| Coordination for the Improvement of Higher Education Personnel | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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New devices have been used in intensive care to optimize respiratory function in critically ill patients, such as automatic lateralization therapy. However, the times and angles used vary widely, and there is no clear evidence of cardiovascular safety and immediate effects, which represents a gap in the literature. This quasi-experimental study aims to evaluate the imediact efficacy and cardiorespiratory safety of automatic lateralization therapy in critically ill patients under invasive mechanical ventilation. The primary outcomes include changes in ventilation distribution and end-expiratory impedance variation. Secondary outcomes include respiratory mechanics, vital signs, and adverse events.
Introduction: Electrical impedance tomography (EIT) enables real-time imaging of lung ventilation, guiding interventions such as automatic lateralization therapy. Despite its potential, evidence about immediate effects and safety is limited.
Objective: To evaluate the imediact cardiorespiratory efficacy and safety of automatic lateralization therapy in critically ill patients.
Method: Quasi-experimental, non-randomized, two-arm study. Participants aged ≥18 years, intubated and clinically stable, will undergo both interventions.
Interventions:
Outcomes: Ventilation distribution, impedance variation (ΔZ, ΔEELZ), respiratory mechanics, adverse events, and vital signs will be measured.
Ethical approval has been granted (CAAE 70188523.0.0000.5200). Informed consent will be obtained from legal guardians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic lateralization therapy | Active Comparator | Participants will undergo automatic lateral positioning using a motorized bed programmed to alternate angles of 0°, 15°, and 30°, switching sides continuously. |
|
| Supine position | Active Comparator | Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automatic lateralization therapy | Other | Program the bed to vary angle and time continuously during the intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ) | Represents the change in regional pulmonary aeration between the pre- and post-intervention moments. | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
| Electrical impedance tomography (EIT): Ventilation Distribution Variation (ΔZ) | Represents the change in ventilation distribution before and after the intervention. | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Monitoring of serious and non-serious adverse events associated with the intervention through an adapted adverse event form | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
| Respiratory Mechanics |
| Measure | Description | Time Frame |
|---|---|---|
| Lung morphofunctional pattern | Type of pattern of lung alteration observed by functional electrical impedance tomography image (preserved, unilateral involvement, unilateral dorsal, bilateral, bilateral dorsal). | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shirley Lima Campos, PhD | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Geral Otávio de Freitas | Recife | Pernambuco | 50920-460 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20507660 | Background | American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64. | |
| 8324411 | Background | Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7. |
| Label | URL |
|---|---|
| Multicare: cama articulável para cuidado intensivo | View source |
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Upon reasonable request, anonymized data will be made available for scientific use, as:
End of trial
Individual participant data (IPD) access will be granted by the PI after request review for approval via email. It will be shared with researchers and general public of interest on the subject for descriptive analyses related to our sample medical and clinical characteristics. A committee of researchers will be in charge of discussing the request before approving the access.
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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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| ID | Term |
|---|---|
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Fundação de Amparo à Ciência e Tecnologia de Pernambuco | OTHER |
This study is a quasi-experimental, before-and-after study, and contains a single group, in which the group itself is the control. There will be a comparison before, during and after the intervention.
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| Supine Positioning | Other | In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30° |
|
|
Data provided through the mechanical ventilator and from inspiratory and expiratory pause maneuvers |
| In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
| Vital signs | Viewed on the multiparameter monitor | In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern. |
| 8364672 | Background | Doering LV. The effect of positioning on hemodynamics and gas exchange in the critically ill: a review. Am J Crit Care. 1993 May;2(3):208-16. |
| 24364779 | Background | Doerschug KC, Schmidt GA. Intensive care ultrasound: III. Lung and pleural ultrasound for the intensivist. Ann Am Thorac Soc. 2013 Dec;10(6):708-12. doi: 10.1513/AnnalsATS.201308-288OT. No abstract available. |
| 27596161 | Background | Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5. |
| 16556959 | Background | Hassan AA, Evrensel CA, Krumpe PE. Clearance of viscoelastic mucus simulant with airflow in a rectangular channel, an experimental study. Technol Health Care. 2006;14(1):1-11. |
| 11018445 | Background | Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4. |
| 30896557 | Background | Kang SY, DiStefano MJ, Yehia F, Koszalka MV, Padula WV. Critical Care Beds With Continuous Lateral Rotation Therapy to Prevent Ventilator-Associated Pneumonia and Hospital-Acquired Pressure Injury: A Cost-effectiveness Analysis. J Patient Saf. 2021 Mar 1;17(2):149-155. doi: 10.1097/PTS.0000000000000582. |
| 29430403 | Background | Molina FJ, Rivera PT, Cardona A, Restrepo DC, Monroy O, Rodas D, Barrientos JG. Adverse events in critical care: Search and active detection through the Trigger Tool. World J Crit Care Med. 2018 Feb 4;7(1):9-15. doi: 10.5492/wjccm.v7.i1.9. eCollection 2018 Feb 4. |
| 34976527 | Background | Politi S, Aloisi A Jr, Bartoli V, Guglietta A, Magnifica F. Infrared Thermography Images Acquisition for a Technical Perspective in Screening and Diagnostic Processes: Protocol Standardized Acquisition. Cureus. 2021 Nov 27;13(11):e19931. doi: 10.7759/cureus.19931. eCollection 2021 Nov. |
| 35150355 | Background | Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9. |
| 19789440 | Background | Staudinger T, Bojic A, Holzinger U, Meyer B, Rohwer M, Mallner F, Schellongowski P, Robak O, Laczika K, Frass M, Locker GJ. Continuous lateral rotation therapy to prevent ventilator-associated pneumonia. Crit Care Med. 2010 Feb;38(2):486-90. doi: 10.1097/CCM.0b013e3181bc8218. |
| 8324412 | Background | Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6. |
| 32712584 | Background | Volpe MS, Guimaraes FS, Morais CC. Airway Clearance Techniques for Mechanically Ventilated Patients: Insights for Optimization. Respir Care. 2020 Aug;65(8):1174-1188. doi: 10.4187/respcare.07904. |
| 22229679 | Background | Wanless S, Aldridge M. Continuous lateral rotation therapy - a review. Nurs Crit Care. 2012 Jan-Feb;17(1):28-35. doi: 10.1111/j.1478-5153.2011.00458.x. Epub 2011 Jul 20. |