Clinical trial NCT04176445: Body Positioning and Pulmonary Aeration During Mechanical Ventilation
Official title: Influence of Body Positioning on Pulmonary Aeration Among Mechanically Ventilated Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critical Illness
Keywords: Critical Care
Sitting Position
Tilt Table
Ultrasonography
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Hospital Ernesto Dornelles
First posted: 2019-11-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Lung Aeration Scores Post Intervention (Verticalization)
timeFrame: 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:
measure: Tidal Volume
timeFrame: 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).
measure: Minute Volume
timeFrame: 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)
measure: Number of Professionals for Verticalization
timeFrame: 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)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
Study officials:
affiliation: Experimental Physiology Laboratory - Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
name: Pedro Dal Lago
role: STUDY_DIRECTOR
affiliation: Intensive Care Unit, Hospital Moinhos de Vento
name: Regis Gourlart Rosa
role: STUDY_DIRECTOR
References:
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