Trial Outcomes & Findings for Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury (NCT NCT03317288)

NCT ID: NCT03317288

Last Updated: 2021-06-09

Results Overview

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes
• Results posted on: 2021-06-09

Participant Flow

Participant milestones

Measure	SCI Subjects The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay. Dabir Air overlay: The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury

Baseline characteristics by cohort

Measure	SCI Subjects n=15 Participants The subject act as his or her own control. Each subject will undergo two procedures, intervention: alternating pressure overlay on top of standard operation room overlay, vs. control: operation room overlay. Dabir Air overlay: The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.87 years STANDARD_DEVIATION 14.89 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	11 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	2 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
body mass index	26.81 kg/m2 STANDARD_DEVIATION 4.13 • n=5 Participants
duration of spinal cord injury	17 years STANDARD_DEVIATION 14.62 • n=5 Participants
level of spinal cord injury At T6 and above	6 Participants n=5 Participants
level of spinal cord injury Below T6	9 Participants n=5 Participants
American Spinal Injury Association Scale score Complete	5 Participants n=5 Participants
American Spinal Injury Association Scale score Incomplete	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Sacral Skin Blood Flow During Supine Lying	12.65 arbitrary unit Standard Deviation 12.45	15.54 arbitrary unit Standard Deviation 15.33	11.96 arbitrary unit Standard Deviation 10.26

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad with and without alternating pressure overlay

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Heel Skin Blood Flow During Supine Lying	15.10 arbitrary unit Standard Deviation 20.78	27.92 arbitrary unit Standard Deviation 32.15	10.43 arbitrary unit Standard Deviation 11.16

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the sacrum.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Sacral Peak Interface Pressure During Supine Lying	89.27 mmHg Standard Deviation 53.92	51.47 mmHg Standard Deviation 30.18	114.13 mmHg Standard Deviation 60.97

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the sacrum.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Sacral Averaged Interface Pressure During Supine Lying	57.21 mmHg Standard Deviation 28.54	36.16 mmHg Standard Deviation 18.47	81.50 mmHg Standard Deviation 46.39

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel peak interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the maximum interface pressure of the nine pressure cells located at the heel.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Heel Peak Interface Pressure During Supine Lying	52.49 mmHg Standard Deviation 21.21	26.79 mmHg Standard Deviation 12.91	53.05 mmHg Standard Deviation 18.22

PRIMARY outcome

Timeframe: 40 minutes, the inflation-deflation cycle alternates every 10 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel averaged interface pressure measured using pressure mapping system during supine lying on operating room pad with and without alternating pressure overlay. This is the averaged interface pressure of the nine pressure cells located at the heel.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) n=15 Participants Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Heel Averaged Interface Pressure During Supine Lying	37.88 mmHg Standard Deviation 17.27	14.60 mmHg Standard Deviation 8.37	34.83 mmHg Standard Deviation 16.62

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Sacral Skin Blood Flow	15.78 arbitrary unit Standard Deviation 15.82	11.96 arbitrary unit Standard Deviation 10.26	—

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Sacral Peak Interface Pressure	104.62 mmHg Standard Deviation 58.17	114.13 mmHg Standard Deviation 60.97	—

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Sacral averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Sacral Averaged Interface Pressure	81.07 mmHg Standard Deviation 48.62	81.50 mmHg Standard Deviation 46.39	—

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel skin blood flow measured using laser Doppler flowmetry system (moor instrument) during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Heel Skin Blood Flow	16.31 arbitrary unit Standard Deviation 29.18	10.43 arbitrary unit Standard Deviation 11.16	—

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel peak interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Heel Peak Interface Pressure	47.69 mmHg Standard Deviation 16.21	53.05 mmHg Standard Deviation 18.22	—

SECONDARY outcome

Timeframe: 40 minutes

Population: All participants with spinal cord injury. Each participant serves as his/her own control.

Heel averaged interface pressure during supine lying on operating room pad after 40 minutes on operating room pad with or without alternating pressure and a 30 minutes washout period.

Outcome measures

Measure	Alternating Pressure -- Inflation Cycle n=15 Participants Averaged skin blood flow during the inflation cycle of the alternating pressure	Alternating Pressure -- Deflation Cycle n=15 Participants Averaged skin blood flow during the deflation cycle of the alternating pressure	Control (Operating Room Pad Only) Averaged skin blood flow during supine lying on the operating room pad only (without alternating pressure overlay)
Post Alternating Pressure Heel Averaged Interface Pressure	30.35 mmHg Standard Deviation 17.59	34.83 mmHg Standard Deviation 16.62	—

Adverse Events

SCI Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yi-Ting Tzen

UT Southwestern Medical Center

Phone: 2146481786

Email: Yi-Ting.Tzen@UTSouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place