Body Positioning and Pulmonary Aeration During Mechanical Ventilation

NCT04176445 | Terminated Results

• 1 other identifier: 3.243.829
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Critical Illness

Keywords

Critical Care; Sitting Position; Tilt Table; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Tidal Volume

  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).

• Minute Volume

  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

  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)

Study Arms (2)

Bedside Sitting followed by Orthostatic Board

OTHER

Bedside sitting posture protocol followed by orthostatic board posture protocol.

Device: Orthostatic board posture; Other: Bedside sitting posture

Orthostatic Board followed by Bedside Sitting

OTHER

Orthostatic board posture protocol followed by bedside sitting posture protocol.

Device: Orthostatic board posture; Other: Bedside sitting posture

Interventions

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

Bedside Sitting followed by Orthostatic Board; Orthostatic Board followed by Bedside Sitting

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.

Bedside Sitting followed by Orthostatic Board; Orthostatic Board followed by Bedside Sitting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients using vasoative drugs (noradrenaline \> 0.2mcg/kg/min or sodium nitroprosside \> 1mcg/kg/min);
• Increase \> 50% in noradrenaline dose in the last 2 hours; since exceeds 0,1 mcg / kg / min in that period;
• Heart rate less than 40 beats per min or more than 130 beats per min
• Active myocardial ischaemia;
• Systolic blood pressure more than 200 mmHg,
• Mean arterial blood pressure less than 65 mm Hg or more than 110 mm Hg;
• Arrhythmia
• Intra-aortic balloon
• RASS \<-4 ou \> +1;
• Intracranial hypertension;
• Patient agitation
• External ventricular drain;
• Neurologic and/or orthopedic conditions that prevented orthostatism
• spinal cord injury) or
• Spinal cord injury and/or risk od instabilitity

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Hospital Ernesto Dornelles: collaborator

Study Sites (2)

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Brazil

Location

Related Publications (13)

• 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.

  PMID: 30327334 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.

  PMID: 19234100 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.

  PMID: 25215147 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.

  PMID: 25307087 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.

  PMID: 15605335 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.

  PMID: 26961919 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.

  PMID: 20522353 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.

  PMID: 14695718 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.

  PMID: 19633538 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.

  PMID: 17316468 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.

  PMID: 20851923 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.

  PMID: 22584759 BACKGROUND

• 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.

  PMID: 38265318 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* First, just over 50% of the sample target was met; however, the early interruption of the study was necessary due to the health reality imposed by the COVID-19 pandemic. * Second, due to the nature of the interventions, it is not possible to blind the assessments, which may have led to measurement bias and the Hawthorn effect. * Third, in addition to the small sample, the study was limited to 2 hospitals, which may limit the external validity in other contexts.

Results Point of Contact

• Title: PT Douglas Neves
• Organization: Hospital Moinhos de Vento

nevesfisioup@gmail.com

(51) 9.98975514

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: November 25, 2019
• Study Start: December 3, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 13, 2021
• Results First Posted: December 13, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)