Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

NCT ID: NCT01668875

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-10-31

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.

Conditions

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Traumatic Blunt Chest and/or Blunt Abdominal Injury

Keywords

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head down postural drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment condition

In intervention period patients were received head-down 30 degree postural drainage position for 10 min.

Group Type EXPERIMENTAL

Head down 30 degree postural drainage position

Intervention Type OTHER

supine head down 30 degree on tilt table (intervention period in the treatment condition)

Sham condition

In intervention period patients were received horizontal supine lying for 10 min.

Group Type EXPERIMENTAL

Horizontal supine lying

Intervention Type OTHER

horizontal supine lying on tilt table (intervention period in the sham condition)

Interventions

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Head down 30 degree postural drainage position

supine head down 30 degree on tilt table (intervention period in the treatment condition)

Intervention Type OTHER

Horizontal supine lying

horizontal supine lying on tilt table (intervention period in the sham condition)

Intervention Type OTHER

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Kantharakorn Hongrattana

Principal vinvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mr.Kantharakorn Hongrattana, master

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy, Khon Kaen Hospital

Locations

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Khon Kaen Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 24655936 (View on PubMed)

Other Identifiers

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KKU-AMS-PT

Identifier Type: -

Identifier Source: org_study_id