Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

November 17, 2012 updated by: Kantharakorn Hongrattana, Khon Kaen University

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Khon Kaen, Thailand, 40000
        • Khon Kaen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
supine head down 30 degree on tilt table (intervention period in the treatment condition)
Experimental: Sham condition
In intervention period patients were received horizontal supine lying for 10 min.
horizontal supine lying on tilt table (intervention period in the sham condition)

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).
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mr.Kantharakorn Hongrattana, master, Department of Physical Therapy, Khon Kaen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 17, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

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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