Traumatic Blunt Chest and/or Blunt Abdominal InjuryNCT01668875
Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position
A study testing Head down 30 degree postural drainage position and Horizontal supine lying in people with Traumatic Blunt Chest and/or Blunt Abdominal Injury, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Traumatic Blunt Chest and/or Blunt Abdominal Injury
- What is being tested?
- Head down 30 degree postural drainage position and Horizontal supine lying
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Head down 30 degree postural drainage position, Horizontal supine lying
- Keywords
- head down postural drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head down 30 degree postural drainage positionOther
supine head down 30 degree on tilt table (intervention period in the treatment condition)
Horizontal supine lyingOther
horizontal supine lying on tilt table (intervention period in the sham condition)
| Study group | Role | What they receive |
|---|---|---|
| Treatment condition | Experimental | In intervention period patients were received head-down 30 degree postural drainage position for 10 min. Receives: Other: Head down 30 degree postural drainage position |
| Sham condition | Experimental | In intervention period patients were received horizontal supine lying for 10 min. Receives: Other: Horizontal supine lying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of heart rate (HR) from baseline.
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: measured every 2 minutes during each phase
Change of systolic blood pressure (SBP) from baseline.
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: measured every 2 minutes during each phase
Change of diastolic blood pressure (DBP) from baseline.
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: measured every 2 minutes during each phase
Change of mean arterial pressure (MAP) from baseline.
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: measured every 2 minutes during each phase
Change of central venous pressure (CVP) from baseline.
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).
Measured: measures every 2 minutes in each phase
Change of respiratory rate (RR) from baseline.
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).
Measured: measures every 2 minutes in each phase
Change of tidal volume (VT) from baseline
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: measured every 2 minutes during each phase
Change of minute ventilation (VE) from baseline
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: measured every 2 minutes during each phase
Change of dynamic lung compliance (Cdyn) from baseline.
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: measured every 2 minutes during each phase
Change of end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline
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: measured every 2 minutes during each phase
Change of oxygen saturation (SpO2) from baseline
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: measured every 2 minutes during each phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Blunt Chest and/or Blunt Abdominal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kantharakorn Hongrattana, Khon Kaen University
- Investigators
- Mr.Kantharakorn Hongrattana, master, Principal investigator, Department of Physical Therapy, Khon Kaen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668875
- Sponsor's protocol ID
- KKU-AMS-PT
- Status last verified
- Nov 2012
- First submitted
- 25 Jun 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24655936
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic and Ventilatory Responses to Head-down 30° Postural Drainage Position in Critically Traumatic Patients
- ClinicalTrials.gov ID
- NCT01668875
- Acronym / sponsor ID
- KKU-AMS-PT
- Keywords
- head down postural drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment condition | Experimental | Other: Head down 30 degree postural drainage positionIn intervention period patients were received head-down 30 degree postural drainage position for 10 min. |
| Sham condition | Experimental | Other: Horizontal supine lyingIn intervention period patients were received horizontal supine lying for 10 min. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head down 30 degree postural drainage positionsupine head down 30 degree on tilt table (intervention period in the treatment condition) | Other | Treatment condition |
| Horizontal supine lyinghorizontal supine lying on tilt table (intervention period in the sham condition) | Other | Sham condition |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Derived from this study: PubMed 24655936Hongrattana 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr.Kantharakorn Hongrattana, master principal investigator
Department of Physical Therapy, Khon Kaen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head down 30 degree postural drainage position and Horizontal supine lying in people with Traumatic Blunt Chest and/or Blunt Abdominal Injury, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of heart rate (HR) from baseline. (time frame: measured every 2 minutes during each phase). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.