Hemodynamic and Ventilatory Responses to Head-down Postural Drainage Position

Not Applicable

Completed

• Conditions: Traumatic Blunt Chest and/or Blunt Abdominal Injury
• Interventions: Other: Horizontal supine lying; Other: Head down 30 degree postural drainage position

• Registration Number: NCT01668875
• Lead Sponsor: Khon Kaen University

Brief 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.

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 Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Study Start: 2012-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-17
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham condition	Horizontal supine lying	In intervention period patients were received horizontal supine lying for 10 min.
Treatment condition	Head down 30 degree postural drainage position	In intervention period patients were received head-down 30 degree postural drainage position for 10 min.

Primary Outcome Measures

Name	Time	Method
Change of mean arterial pressure (MAP) from baseline.	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.	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 minute ventilation (VE) from baseline	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.	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 systolic blood pressure (SBP) from baseline.	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.	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 respiratory rate (RR) from baseline.	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 heart rate (HR) from baseline.	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 end-tidal expiratory pressure of carbon dioxide (PETCO2) from baseline	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 tidal volume (VT) from baseline	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 oxygen saturation (SpO2) from baseline	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).

Trial Locations

Locations (1)

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand