NCT02739841

Brief Summary

The purpose of this study is to explore acute hemodynamic responses to VHI technique in critical traumatic patients with pulmonary complications in the intensive care unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

January 28, 2016

Last Update Submit

June 5, 2024

Conditions

Pulmonary Complications

Keywords

hemodynamic response

Outcome Measures

Primary Outcomes (1)

  • Mean arterial pressure (MAP)

    Change from baseline in mean arterial pressure (MAP)

    "change from baseline in mean arterial pressure (MAP) at during intervention" and "change from baseline in mean arterial pressure (MAP) at immediately after intervention"

Secondary Outcomes (4)

  • Heart rate (HR)

    "change from baseline in heart rate (HR) at during intervention" and "change from baseline in heart rate (HR) at immediately after intervention"

  • Systolic blood pressure (SBP)

    "change from baseline in systolic blood pressure (SBP) at during intervention" and "change from baseline in systolic blood pressure (SBP) at immediately after intervention"

  • Diastolic blood pressure (DBP)

    "change from baseline in diastolic blood pressure (DBP) at during intervention" and "change from baseline in diastolic blood pressure (DBP) at immediately after intervention"

  • Central venous pressure (CVP)

    "change from baseline in central venous pressure (CVP) at during intervention" and "change from baseline in central venous pressure (CVP) at immediately after intervention"

Study Arms (2)

Ventilator hyperinflation

EXPERIMENTAL

For the ventilator hyperinflation techniques (VHI), the study consists of three consecutive periods 1) baseline period: 10 minutes rest in side lying by effected lung uppermost with head-up 30 degree 2) Intervention period: Patients were positioned as same as baseline period and 4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial 3) recovery period: 10 minutes rest in the same position but reduce VT to initial.

Other: Ventilator hyperinflation

Chest physical therapy

EXPERIMENTAL

For the conventional chest physical therapy (CPT), the study will be performed in the similar procedure except the intervention period, the patient will be received vibration and passive of the both upper extremity.

Other: Chest physical therapy

Interventions

Ventilator hyperinflationOTHER

4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.

Ventilator hyperinflation
Chest physical therapyOTHER

The patient will be received vibration and passive of the both upper extremity.

Chest physical therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Mechanical ventilator dependence

You may not qualify if:

  • acute respiratory distress syndrome (ARDS)
  • acute lung injury (ALI)
  • pulmonary contusion
  • undrained pneumothorax, hemothoarax, and hemopneumothorax
  • bronchospasm
  • pulmonary bullae/blebs
  • lung tumors
  • lung abscess
  • haemoptysis
  • mean arterial pressure (MAP) \<70 mmHg
  • positive end expiratory pressure (PEEP) \>6 cm H2O
  • heart rate (HR) \> 140 beats/min
  • blood pressure (BP) \<90/60 or \>180/100 mmHg
  • restlessness
  • oxygen saturation (SpO2) \< 90 %
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of physical therapy, Faculty of Associated Medical Science, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Study Officials

  • Atsadang Natisri, Master

    school of physical therapy, faculty of associated medical sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

April 15, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 6, 2024

Record last verified: 2024-06

Locations

TH(1)