Body Positioning and Pulmonary Aeration During Mechanical Ventilation

Not Applicable

Terminated

• Conditions: Critical Illness
• Interventions: Device: Orthostatic board posture; Other: Bedside sitting posture

• Registration Number: NCT04176445
• Lead Sponsor: Hospital Moinhos de Vento

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-19
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Study Start: 2019-12-03
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Results First Submitted: 2021-08-24
• Results First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Results First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

18 years or older; Invasive Mechanical Ventilation > 24 hours; no weaning expectation on screening day for study eligibility; Signature of Informed Consent.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bedside Sitting followed by Orthostatic Board	Bedside sitting posture	Bedside sitting posture protocol followed by orthostatic board posture protocol.
Orthostatic Board followed by Bedside Sitting	Orthostatic board posture	Orthostatic board posture protocol followed by bedside sitting posture protocol.
Orthostatic Board followed by Bedside Sitting	Bedside sitting posture	Orthostatic board posture protocol followed by bedside sitting posture protocol.
Bedside Sitting followed by Orthostatic Board	Orthostatic board posture	Bedside sitting posture protocol followed by orthostatic board posture protocol.

Primary Outcome Measures

Name	Time	Method
Lung Aeration Scores Post Intervention (Verticalization)	Single day assessment post intervention of the sitting posture (protocol lasts 30 minutes) and post intervention of the standing board (protocol lasts 30 minutes)	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.

Secondary Outcome Measures

Name	Time	Method
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).	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
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)	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
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)	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

Trial Locations

Locations (2)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Brazil

Hospital Ernesto Dornelles; 🇧🇷 Porto Alegre, Brazil