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Body Positioning and Pulmonary Aeration During Mechanical Ventilation

Primary Purpose

Critical Illness

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orthostatic board posture
Bedside sitting posture
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Critical Care, Sitting Position, Tilt Table, Ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Ernesto Dornelles
  • Hospital Moinhos de Vento

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bedside Sitting followed by Orthostatic Board

Orthostatic Board followed by Bedside Sitting

Arm Description

Bedside sitting posture protocol followed by orthostatic board posture protocol.

Orthostatic board posture protocol followed by bedside sitting posture protocol.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
October 19, 2019
Last Updated
November 3, 2021
Sponsor
Hospital Moinhos de Vento
Collaborators
Hospital Ernesto Dornelles
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1. Study Identification

Unique Protocol Identification Number
NCT04176445
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
The trial was stopped prematurely due to the COVID-19 pandemic
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Hospital Ernesto Dornelles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Critical Care, Sitting Position, Tilt Table, Ultrasonography

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bedside Sitting followed by Orthostatic Board
Arm Type
Other
Arm Description
Bedside sitting posture protocol followed by orthostatic board posture protocol.
Arm Title
Orthostatic Board followed by Bedside Sitting
Arm Type
Other
Arm Description
Orthostatic board posture protocol followed by bedside sitting posture protocol.
Intervention Type
Device
Intervention Name(s)
Orthostatic board posture
Intervention Description
Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes
Intervention Type
Other
Intervention Name(s)
Bedside sitting posture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung Aeration Scores Post Intervention (Verticalization)
Description
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.
Time Frame
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 Measure Information:
Title
Tidal Volume
Description
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
Time Frame
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).
Title
Minute Volume
Description
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
Time Frame
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)
Title
Number of Professionals for Verticalization
Description
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
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Dal Lago
Organizational Affiliation
Experimental Physiology Laboratory - Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Regis Gourlart Rosa
Organizational Affiliation
Intensive Care Unit, Hospital Moinhos de Vento
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30327334
Citation
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Results Reference
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19234100
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.
Results Reference
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PubMed Identifier
25215147
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.issn.1920-8642.2014.01.008.
Results Reference
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PubMed Identifier
25307087
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.
Results Reference
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PubMed Identifier
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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. doi: 10.1016/j.apmr.2004.03.024.
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Body Positioning and Pulmonary Aeration During Mechanical Ventilation

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