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Completed

NCT Number: NCT01668875

Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

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.

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Key information

Conditions

Traumatic Blunt Chest and/or Blunt Abdominal Injury

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen Hospital

Khon Kaen, Changwat Khon Kaen, 40000, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head down 30 degree postural drainage position

Other

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

Horizontal supine lying

Other

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2012
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.