Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

Study Overview
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Brief Summary
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The purpose of this study is to explore acute hemodynamic and ventilatory responses to head-down 30 degree postural drainage position in patients with blunt chest and/or abdominal injury in the traumatic intensive care unit.

Detailed Description
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Study Protocol The study protocol consisted of 2 conditions: treatment condition (A) and sham condition (B). The order of the conditions was randomly assigned to either the treatment or sham for the first round and vise versa in the second round in a balanced cross-over design (A-B-B-A) so there were four sets of measurements per patient. For the treatment condition (A), the study consists of three consecutive periods 1) baseline period: 10 minutes rest in horizontal supine lying 2) intervention period: 10 minutes rest in head-down 30 degree supine lying 3) recovery period: return to horizontal supine lying and rest for 10 minutes . For the Sham condition (B), the study was performed with a similar procedure except the intervention period consisted of horizontal supine lying. Hemodynamic and ventilatory parameter were recorded at the start of each period (0 min) and every 2 minute until end of each period for both conditions. Hemodynamic and ventilatory dependent variables were heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), electrocardiography (ECG), central venous pressure (CVP), respiratory rate (RR), oxygen saturation (SpO2), tidal volume (VT), minute ventilation (VE), dynamic lung compliance (Cdyn) and end-tidal expiratory pressure of CO2 (PETCO2). Subjects were rested between each condition. Subjects were suctioned via endotracheal tube to clear airway at 10 minutes before study commencement of either A-B or B-A.

Official Title
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Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients

Conditions
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Traumatic Blunt Chest and/or Blunt Abdominal Injury

Intervention / Treatment
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* Other: Head down 30 degree postural drainage position
* Other: Horizontal supine lying


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical ventilator dependence Stable cardiopulmonary function at rest (HR 60-100 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg and SpO2>95%. RR 10-20 breath/min Exclusion Criteria: Spine disorders such as spine fracture, HNP, spondylolisthesis, whiplash syndrome, stenosis and spondylosis Fracture of upper and/or lower limbs Underlying acute or chronic cardiopulmonary diseases Craniotomy or craniectomy Unstable intracranial pressure, ICP>12 cmH2O Uncontrolled pain

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment condition<br>In intervention period patients were received head-down 30 degree postural drainage position for 10 min. | Other: Head down 30 degree postural drainage position<br>* supine head down 30 degree on tilt table (intervention period in the treatment condition)<br>|
| Experimental: Sham condition<br>In intervention period patients were received horizontal supine lying for 10 min. | Other: Horizontal supine lying<br>* horizontal supine lying on tilt table (intervention period in the sham condition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of heart rate (HR) from baseline. | Heart rate (HR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of systolic blood pressure (SBP) from baseline. | Systolic blood pressure (SBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of diastolic blood pressure (DBP) from baseline. | Diastolic blood pressure (DBP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of mean arterial pressure (MAP) from baseline. | Mean arterial pressure (MAP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of central venous pressure (CVP) from baseline. | central venous pressure (CVP) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measures every 2 minutes in each phase | 
| Change of respiratory rate (RR) from baseline. | respiratory rate (RR) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measures every 2 minutes in each phase | 
| Change of tidal volume (VT) from baseline | tidal volume (VT) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of minute ventilation (VE) from baseline | minute ventilation (VE) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of dynamic lung compliance (Cdyn) from baseline. | dynamic lung compliance (Cdyn) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline | end-tidal expiratory pressure of carbon dioxide (PETCO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 
| Change of oxygen saturation (SpO2) from baseline | oxygen saturation (SpO2) was recorded 3 times every 2 minute in each phase, each phase will have 10 minutes and each condition will have 3 phases (baseline, intervention, and recovery). | measured every 2 minutes during each phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head down postural drainage