Trial Outcomes & Findings for Body Positioning and Pulmonary Aeration During Mechanical Ventilation (NCT NCT04176445)

Last Updated: 2021-12-13

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

19 participants

Primary outcome 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)

Results posted on

2021-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Bedside Sitting (First Intervention) Followed by Orthostatic Board (Second Intervention) Bedside sitting posture protocol followed by orthostatic board posture protocol. 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 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.	Orthostatic Board (First Intervention) Followed by Bedside Sitting (Second Intervention) Orthostatic board posture protocol followed by bedside sitting posture protocol. 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 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.
Overall Study STARTED	12	7
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bedside Sitting (First Intervention) Followed by Orthostatic Board (Second Intervention) Bedside sitting posture protocol followed by orthostatic board posture protocol. 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 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.	Orthostatic Board (First Intervention) Followed by Bedside Sitting (Second Intervention) Orthostatic board posture protocol followed by bedside sitting posture protocol. 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 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.
Overall Study Adverse Event	0	1
Overall Study change plans weaning after first intervention	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=19 Participants Study participants were randomized to Bedside sitting (first intervention) posture protocol followed by orthostatic board (second intervention) posture protocol or Orthostatic board (first intervention) posture protocol followed by bedside sitting posture (second intervention) protocol. 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 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.
Age, Continuous	73.2 years STANDARD_DEVIATION 13.7 • n=19 Participants
Sex: Female, Male Female	8 Participants n=19 Participants
Sex: Female, Male Male	11 Participants n=19 Participants
Region of Enrollment Brazil	19 participants n=19 Participants
Charlson comorbidity index	3.2 score STANDARD_DEVIATION 1.7 • n=19 Participants
Reason for mechanical ventilation Acute respiratory failure	11 Participants n=19 Participants
Reason for mechanical ventilation Hemodynamic instability	1 Participants n=19 Participants
Reason for mechanical ventilation Decreased level of consciousness	5 Participants n=19 Participants
Reason for mechanical ventilation Cardiac arrest	2 Participants n=19 Participants
Duration of Invasive Mechanical Ventilation	4.3 days STANDARD_DEVIATION 1.1 • n=19 Participants
ICU admission type Medical	18 Participants n=19 Participants
ICU admission type Surgical	1 Participants n=19 Participants
Simplified Acute Physiology Score 3	71.6 score STANDARD_DEVIATION 10.8 • n=19 Participants
Continuous parenteral sedation	3 Participants n=19 Participants
Richmond Agitation-Sedation Scale	-4 score STANDARD_DEVIATION 1.1 • n=19 Participants
Mode of mechanical ventilation Presure Support Ventilation	13 Participants n=19 Participants
Mode of mechanical ventilation Pressure Control Continuous Mandatory Ventilation	6 Participants n=19 Participants

PRIMARY outcome

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)

Outcome measures

Outcome measures
Measure	Bedside Sitting n=17 Participants Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.	Orthostatic Board n=19 Participants Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
Lung Aeration Scores Post Intervention (Verticalization)	13.7 score on a scale Standard Deviation 7.6	11.0 score on a scale Standard Deviation 8.0

SECONDARY outcome

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).

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

Outcome measures

Outcome measures
Measure	Bedside Sitting n=17 Participants Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.	Orthostatic Board n=19 Participants Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
Tidal Volume	435 ml Interval 380.0 to 480.0	436 ml Interval 396.0 to 507.0

SECONDARY outcome

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)

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

Outcome measures

Outcome measures
Measure	Bedside Sitting n=17 Participants Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.	Orthostatic Board n=19 Participants Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
Minute Volume	11.1 L/min Interval 8.4 to 12.2	10.3 L/min Interval 8.7 to 12.5

SECONDARY outcome

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)

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

Outcome measures

Outcome measures
Measure	Bedside Sitting n=17 Participants Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.	Orthostatic Board n=19 Participants Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
Number of Professionals for Verticalization	3 professionals per procedure Interval 3.0 to 3.3	3 professionals per procedure Interval 3.0 to 3.0

Adverse Events

Bedside Sitting

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Orthostatic Board

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bedside Sitting n=17 participants at risk Bedside sitting posture: Patients were placed at the bedside, with support for the back and upper limbs. They were kept at 90º of hip and knee flexion and feet supported. The total posture protocol were last 30 minutes.	Orthostatic Board n=19 participants at risk Orthostatic board posture: Patients were verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol were last 30 minutes
Cardiac disorders Hypontension	5.9% 1/17 • Number of events 1 • The evaluations took place in a single moment/day. Possible adverse events were evaluated from randomization to the last assessment of the outcome.	10.5% 2/19 • Number of events 2 • The evaluations took place in a single moment/day. Possible adverse events were evaluated from randomization to the last assessment of the outcome.
Cardiac disorders Tachycardia	0.00% 0/17 • The evaluations took place in a single moment/day. Possible adverse events were evaluated from randomization to the last assessment of the outcome.	5.3% 1/19 • Number of events 1 • The evaluations took place in a single moment/day. Possible adverse events were evaluated from randomization to the last assessment of the outcome.

Additional Information

PT Douglas Neves

Hospital Moinhos de Vento

Phone: (51) 9.98975514

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place