Clinical trial NCT01668875: Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position
Official title: Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Blunt Chest and/or Blunt Abdominal Injury
Keywords: head down postural drainage
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 11
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of heart rate (HR) from baseline.
timeFrame: measured every 2 minutes during each phase
measure: Change of systolic blood pressure (SBP) from baseline.
timeFrame: measured every 2 minutes during each phase
measure: Change of diastolic blood pressure (DBP) from baseline.
timeFrame: measured every 2 minutes during each phase
measure: Change of mean arterial pressure (MAP) from baseline.
timeFrame: measured every 2 minutes during each phase
measure: Change of central venous pressure (CVP) from baseline.
timeFrame: measures every 2 minutes in each phase
measure: Change of respiratory rate (RR) from baseline.
timeFrame: measures every 2 minutes in each phase
measure: Change of tidal volume (VT) from baseline
timeFrame: measured every 2 minutes during each phase
measure: Change of minute ventilation (VE) from baseline
timeFrame: measured every 2 minutes during each phase
measure: Change of dynamic lung compliance (Cdyn) from baseline.
timeFrame: measured every 2 minutes during each phase
measure: Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline
timeFrame: measured every 2 minutes during each phase
measure: Change of oxygen saturation (SpO2) from baseline
timeFrame: measured every 2 minutes during each phase
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen Hospital
Study officials:
affiliation: Department of Physical Therapy, Khon Kaen Hospital
name: Mr.Kantharakorn Hongrattana, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hongrattana G, Reungjui P, Jones CU. Acute hemodynamic responses to 30 degrees head-down postural drainage in stable, ventilated trauma patients: a randomized crossover trial. Heart Lung. 2014 Sep-Oct;43(5):399-405. doi: 10.1016/j.hrtlng.2014.01.011. Epub 2014 Mar 19.