Body Positioning and Pulmonary Aeration During Mechanical Ventilation

November 3, 2021 updated by: Douglas Neves, Hospital Moinhos de Vento

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil
        • Hospital Moinhos de Vento
      • Porto Alegre, Brazil
        • Hospital Ernesto Dornelles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Bedside Sitting followed by Orthostatic Board
Bedside sitting posture protocol followed by orthostatic board posture protocol.
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.
Other: Orthostatic Board followed by Bedside Sitting
Orthostatic board posture protocol followed by bedside sitting posture protocol.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung Aeration Scores Post Intervention (Verticalization)
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tidal Volume
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).
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).
Minute Volume
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)
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)
Number of Professionals for Verticalization
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Moinhos de Vento

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Ernesto Dornelles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pedro Dal Lago, Experimental Physiology Laboratory - Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)
  • Study Director: Regis Gourlart Rosa, Intensive Care Unit, Hospital Moinhos de Vento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3.243.829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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