Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

Traumatic Blunt Chest and/or Blunt Abdominal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668875
• Other study ID #: KKU-AMS-PT
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: November 17, 2012
• Start date: September 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abdominal Injuries
• Traumatic Blunt Chest and/or Blunt Abdominal Injury

Intervention

Other:
• Head down 30 degree postural drainage position
supine head down 30 degree on tilt table (intervention period in the treatment condition)
• Horizontal supine lying
horizontal supine lying on tilt table (intervention period in the sham condition)

Locations

Country	Name	City	State
Thailand	Khon Kaen Hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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).	measures every 2 minutes in each phase	Yes
Primary	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).	measures every 2 minutes in each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes
Primary	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 every 2 minutes during each phase	Yes