- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668875
Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position
Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Khon Kaen, Thailand, 40000
- Khon Kaen Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment condition
In intervention period patients were received head-down 30 degree postural drainage position for 10 min.
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supine head down 30 degree on tilt table (intervention period in the treatment condition)
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Experimental: Sham condition
In intervention period patients were received horizontal supine lying for 10 min.
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horizontal supine lying on tilt table (intervention period in the sham condition)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of heart rate (HR) from baseline.
Time Frame: measured every 2 minutes during each phase
|
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.
Time Frame: measured every 2 minutes during each phase
|
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.
Time Frame: measured every 2 minutes during each phase
|
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.
Time Frame: measured every 2 minutes during each phase
|
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.
Time Frame: measures every 2 minutes in each phase
|
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).
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measures every 2 minutes in each phase
|
Change of respiratory rate (RR) from baseline.
Time Frame: measures every 2 minutes in each phase
|
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
Time Frame: measured every 2 minutes during each phase
|
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
Time Frame: measured every 2 minutes during each phase
|
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.
Time Frame: measured every 2 minutes during each phase
|
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
Time Frame: measured every 2 minutes during each phase
|
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
Time Frame: measured every 2 minutes during each phase
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mr.Kantharakorn Hongrattana, master, Department of Physical Therapy, Khon Kaen Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KKU-AMS-PT
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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