Body Positioning and Pulmonary Aeration During Mechanical Ventilation

Influence of Body Positioning on Pulmonary Aeration Among Mechanically Ventilated Critical Ill Patients

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).

Study Overview

• Status: Terminated
• Conditions: Critical Illness
• Intervention / Treatment: Device: Orthostatic board posture; Other: Bedside sitting posture

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Porto Alegre, Brazil
    • Hospital Moinhos de Vento
  • Porto Alegre, Brazil
    • Hospital Ernesto Dornelles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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;
• Inclusion of norepinephrine in the last 2 hours, with the dose > 0.1mcg/kg/min;
• 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
• Acute stroke;
• orthopedic fractures in the lower limf
• Inability to walk with- out assistance before acute ICU illness (use of a cane or walkers its not exclusions;
• MRC > 3 MMII;
• Major pressure ulcers in the calcaneal region;
• FiO2 > 60%
• Positive end-epiratory pressure > 10cmH2O;
• Pulse oximetry less than 88%
• Respiratory rate less than 5 breaths per min or more than 40 breaths per min
• Neuromuscular blocking;
• Reserved Prognosis;
• Peritoneostomy;
• Temperature> 38.5 °C;
• Active gastrointestinal blood loss
• Intra-abdominal Hypertension;
• Thrombocytopenia (platelet count <50 000);
• Diarrhea;
• Hyperglycemia, with HGT < 70mg/g
• Intermittent haemodialysis
• Large abdominal surgery
• Continuous Epidural infusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bedside Sitting followed by Orthostatic Board; Bedside sitting posture protocol followed by orthostatic board posture protocol.	Device: 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; Other: 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.
Other: Orthostatic Board followed by Bedside Sitting; Orthostatic board posture protocol followed by bedside sitting posture protocol.	Device: 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; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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).
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)

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Collaborators: Hospital Ernesto Dornelles
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasonography; Critical Care; Tilt Table; Sitting Position
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 3.243.829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No