Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kantharakorn Hongrattana, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01668875
First received: June 25, 2012
Last updated: November 17, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Traumatic Blunt Chest and/or Blunt Abdominal Injury
Other: Head down 30 degree postural drainage position
Other: Horizontal supine lying

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Change of heart rate (HR) from baseline. [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of systolic blood pressure (SBP) from baseline. [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of diastolic blood pressure (DBP) from baseline. [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of mean arterial pressure (MAP) from baseline. [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of central venous pressure (CVP) from baseline. [ Time Frame: measures every 2 minutes in each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of respiratory rate (RR) from baseline. [ Time Frame: measures every 2 minutes in each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of tidal volume (VT) from baseline [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of minute ventilation (VE) from baseline [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of dynamic lung compliance (Cdyn) from baseline. [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).

  • Change of oxygen saturation (SpO2) from baseline [ Time Frame: measured every 2 minutes during each phase ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 11
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment condition
In intervention period patients were received head-down 30 degree postural drainage position for 10 min.
Other: Head down 30 degree postural drainage position
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.
Other: Horizontal supine lying
horizontal supine lying on tilt table (intervention period in the sham condition)

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

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668875

Locations
Thailand
Khon Kaen Hospital
Khon Kaen, Thailand, 40000
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Mr.Kantharakorn Hongrattana, master Department of Physical Therapy, Khon Kaen Hospital
  More Information

No publications provided by Khon Kaen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kantharakorn Hongrattana, Principal vinvestigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01668875     History of Changes
Other Study ID Numbers: KKU-AMS-PT
Study First Received: June 25, 2012
Last Updated: November 17, 2012
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Khon Kaen University:
head down postural drainage

Additional relevant MeSH terms:
Abdominal Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014