Body Positioning and Pulmonary Aeration During Mechanical Ventilation

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04176445
• Other study ID #: 3.243.829
• Status: Terminated
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2019
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Ernesto Dornelles	Porto Alegre
Brazil	Hospital Moinhos de Vento	Porto Alegre

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Hospital Ernesto Dornelles

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

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. — View Citation

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. — View Citation

Bouhemad B, Zhang M, Lu Q, Rouby JJ. Clinical review: Bedside lung ultrasound in critical care practice. Crit Care. 2007;11(1):205. Review. — View Citation

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. — View Citation

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.1920-8642.2014.01.008. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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).
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	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	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)