Immediate Effects of Automatic Lateralization in Critically Ill Patients
NCT ID: NCT07087600
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2025-08-14
2025-10-30
Brief Summary
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Detailed Description
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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:
* Arm 1: Supine position with head elevated at 30°.
* Arm 2: Automatic lateralization therapy using programmable bed angles (0°, 15°, and 30°), alternating sides.
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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Automatic lateralization therapy
Participants will undergo automatic lateral positioning using a motorized bed programmed to alternate angles of 0°, 15°, and 30°, switching sides continuously.
Automatic lateralization therapy
Program the bed to vary angle and time continuously during the intervention
Supine position
Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied.
Supine Positioning
In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°
Interventions
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Automatic lateralization therapy
Program the bed to vary angle and time continuously during the intervention
Supine Positioning
In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Of both sexes;
* Breathing through an orotracheal tube;
* With respiratory and hemodynamic stability.
Exclusion Criteria
* Acute spinal cord injury;
* Unstable fractures and signs of intracranial hypertension;
* Pregnant women;
* Immediate postoperative period of thoracic, orthopedic and abdominal surgeries;
* Use of drains;
* Grade III obesity (BMI \> 40 kg/m2);
* Suspected pulmonary thromboembolism;
* Agitation and active bleeding.
18 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Coordination for the Improvement of Higher Education Personnel
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
OTHER
University of Pernambuco
OTHER
Responsible Party
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Shirley Lima Campos
Principal Researcher
Principal Investigators
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Shirley Lima Campos, PhD
Role: STUDY_DIRECTOR
Universidade Federal de Pernambuco
Locations
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Hospital Geral Otávio de Freitas
Recife, Pernambuco, Brazil
Countries
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References
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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.
Maclin VM, Radwanska E, Binor Z, Dmowski WP. Progesterone:estradiol ratios at implantation in ongoing pregnancies, abortions, and nonconception cycles resulting from ovulation induction. Fertil Steril. 1990 Aug;54(2):238-44. doi: 10.1016/s0015-0282(16)53696-6.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.
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.
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.
Related Links
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Multicare: cama articulável para cuidado intensivo
Other Identifiers
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70188523.0.0000.5200
Identifier Type: -
Identifier Source: org_study_id
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