Body Positioning and Pulmonary Aeration During Mechanical Ventilation

NCT ID: NCT04176445

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2020-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bedside Sitting followed by Orthostatic Board

Bedside sitting posture protocol followed by orthostatic board posture protocol.

Group Type: OTHER

Orthostatic board posture

Intervention Type: 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 posture

Intervention Type: 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.

Orthostatic Board followed by Bedside Sitting

Orthostatic board posture protocol followed by bedside sitting posture protocol.

Group Type: OTHER

Orthostatic board posture

Intervention Type: 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 posture

Intervention Type: 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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Ernesto Dornelles

OTHER

Sponsor Role: collaborator

Hospital Moinhos de Vento

OTHER

Sponsor Role: lead

Responsible Party

Douglas Neves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro Dal Lago

Role: STUDY_DIRECTOR

Experimental Physiology Laboratory - Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)

Regis Gourlart Rosa

Role: STUDY_DIRECTOR

Intensive Care Unit, Hospital Moinhos de Vento

Locations

Hospital Ernesto Dornelles

Porto Alegre, , Brazil

Hospital Moinhos de Vento

Porto Alegre, , Brazil

Countries

Brazil

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3.243.829

Identifier Type: -

Identifier Source: org_study_id