Trial Outcomes & Findings for Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma (NCT NCT04909463)

Results Overview

Change in forced vital capacities over time using the device as compared to control groups

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Results posted on

2025-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Unilateral Rib Fractures Only, no Device Intervention Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention
Overall Study STARTED	3	4	1
Overall Study COMPLETED	1	2	0
Overall Study NOT COMPLETED	2	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Unilateral Rib Fractures Only, no Device Intervention Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Overall Study Withdrawal by Subject	0	1	0	0
Overall Study Lost to Follow-up	2	1	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Unilateral Rib Fractures Only, no Device Intervention n=3 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=4 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention n=1 Participants Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=1 Participants	0 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants	3 Participants n=4 Participants	1 Participants n=1 Participants	—	5 Participants n=8 Participants
Age, Categorical >=65 years	2 Participants n=3 Participants	1 Participants n=4 Participants	0 Participants n=1 Participants	—	3 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	2 Participants n=4 Participants	0 Participants n=1 Participants	—	4 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=1 Participants	—	4 Participants n=8 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

Change in forced vital capacities over time using the device as compared to control groups

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
FVC Change	0.06 Liters (L) Standard Deviation 0	0.34 Liters (L) Standard Deviation 0.33	—	—

PRIMARY outcome

Timeframe: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
FEV1 Change	0.03 Liters (L) Standard Deviation 0	0.33 Liters (L) Standard Deviation 0.46	—	—

PRIMARY outcome

Timeframe: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
FEV1 Percent Change	-0.63 Percentage (%) Standard Deviation 0	4.49 Percentage (%) Standard Deviation 12.40	—	—

SECONDARY outcome

Timeframe: Documented at time of discharge, assessed up to 14 days.

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

The length of stay for the entire admission to the time of discharge

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Length of Stay	2 Days Standard Deviation 0	4.5 Days Standard Deviation 2.12	—	—

SECONDARY outcome

Timeframe: 0-48 hours after admission.

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

The initial time of ambulation documented after admission.

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Time to Ambulation	19.8 Hours Standard Deviation 0	22.75 Hours Standard Deviation 3.46	—	—

SECONDARY outcome

Timeframe: Documented within 2 weeks of admission date.

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

Use of the Injury Severity Score to measure the degree of injury and how it affects outcomes associated with the chest splint. This is measured on a scale from 1 to 6; 1 being relatively minor and 6 being untreatable.

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Injury Severity Score	9 score Standard Deviation 0	2.5 score Standard Deviation 2.12	—	—

SECONDARY outcome

Timeframe: Within first 24 hours of admission

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed admission date and time documentation for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Date and time of admission were recorded for clinical documentation purposes. No statistical analysis was performed for this outcome.

Documenting date and time of admission

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Day of Admission	1 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Population: Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data.

Change in vital capacity values indicating changes in deep breathing over the course of hospitalization while using the Duracore device

Outcome measures

Outcome measures
Measure	Unilateral Rib Fractures Only, no Device Intervention n=1 Participants Unilateral rib fractures only, no device intervention	Unilateral Rib Fractures, Device Intervention n=2 Participants Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.	Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention	Bilateral Rib Fractures, Device Intervention Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Vital Capacity Measurement Via Incentive Spirometry	0.20 Liters (L) Standard Deviation 0	0.95 Liters (L) Standard Deviation 0.21	—	—

Adverse Events

Unilateral Rib Fractures Only, no Device Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unilateral Rib Fractures, Device Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bilateral Rib Fractures, no Device Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bilateral Rib Fractures, Device Intervention

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

Trenton Bradbury

CommonSpiritHealth

Phone: 7193730213

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place