Trial Outcomes & Findings for Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury (NCT NCT04912583)

Last Updated: 2025-07-15

Results Overview

The primary outcome is pneumonia episodes with evidence of new or progressive and persistent infiltrate on chest radiograph plus 2 of the following abnormal white blood cell count, presence of fever or hyperthermia, purulent sputum, and deterioration in gas exchange. Any new pneumonia episodes which meet the above criteria and developed 48 hours after achieving target tidal volume will be recorded.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

From the time of enrollment to time of discharge from hospital (about 6 weeks)

Results posted on

2025-07-15

Participant Flow

A total of 62 participants were screened for eligibility. Of those, 31 met the inclusion criteria and signed informed consent. One participant was transferred before randomization and did not continue in the study. A total of 31 participants were enrolled, and 30 were randomized.

Participant milestones

Participant milestones
Measure	High Tidal Volume A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Tidal Volume n=15 Participants A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	High Tidal Volume n=15 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Total n=30 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 13 • n=99 Participants	44 years STANDARD_DEVIATION 17 • n=107 Participants	49 years STANDARD_DEVIATION 15.13 • n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	11 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Region of Enrollment United States	15 participants n=99 Participants	15 participants n=107 Participants	30 participants n=206 Participants
Cause of injury Vehicular	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Cause of injury Fall	4 Participants n=99 Participants	3 Participants n=107 Participants	7 Participants n=206 Participants
Cause of injury Violence	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Cause of injury Medical/Surgical Complications	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Cause of injury Sports	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Cause of injury Other traumatic Injuries	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Asia Impairment Scale Classification A	9 Participants n=99 Participants	11 Participants n=107 Participants	20 Participants n=206 Participants
Asia Impairment Scale Classification B	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Asia Impairment Scale Classification C	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Asia Impairment Scale Classification D	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Number of Participants with a smoking history	5 Participants n=99 Participants	3 Participants n=107 Participants	8 Participants n=206 Participants
Number of participants with a history of lung or pulmonary disorders prior to Spinal Cord Injury	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Number of participants with a history of concomitant mild traumatic brain injury or stroke	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Neurological Level of Spinal Cord Injury (SCI) C1 to C3	7 Participants n=99 Participants	9 Participants n=107 Participants	16 Participants n=206 Participants
Neurological Level of Spinal Cord Injury (SCI) C4 to C5	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants

PRIMARY outcome

Timeframe: From the time of enrollment to time of discharge from hospital (about 6 weeks)

Outcome measures

Outcome measures
Measure	High Tidal Volume n=15 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 Participants A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Number of Episodes of Pneumonia	.13 episodes of pneumonia Standard Deviation .35	.4 episodes of pneumonia Standard Deviation .5

SECONDARY outcome

Timeframe: At the time of consent (within 48 hours of hospital admission)

Recruitment rate is the proportion of eligible people who provide consent.

Outcome measures

Outcome measures
Measure	High Tidal Volume n=62 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Feasibility as Assessed by Recruitment Rate	31 Participants	—

SECONDARY outcome

Timeframe: At the time of start of intervention (within 48 hours of hospital admission)

Adherence rate is the proportion of participants in each group who receive the assigned intervention per protocol.

Outcome measures

Outcome measures
Measure	High Tidal Volume n=15 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 Participants A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Feasibility as Assessed by Adherence Rate	11 Participants	13 Participants

SECONDARY outcome

Timeframe: at the time of discharge from hospital (about 6 weeks after admission)

Retention rate is the number of participants in each group who complete all study procedures.

Outcome measures

Outcome measures
Measure	High Tidal Volume n=15 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 Participants A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Feasibility as Assessed by Retention Rate	15 Participants	15 Participants

SECONDARY outcome

Timeframe: From the time of enrollment to time of discharge from hospital (about 6 weeks)

Outcome measures

Outcome measures
Measure	High Tidal Volume n=15 Participants A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 Participants A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Feasibility as Assessed by Number of Participants With Missing Data	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of enrollment to the time of discharge from the hospital (about 6 weeks)

The following ventilator-associated events will be reported: transfer to acute care hospital due to respiratory complications, weaning failure, new pneumothorax, Acute respiratory distress syndrome (ARDS), pleural effusion, pulmonary embolism, atelectasis, and pulmonary edema.

Outcome measures

Outcome data not reported

Adverse Events

High Tidal Volume

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Low Tidal Volume

Serious events: 1 serious events

Other events: 12 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	High Tidal Volume n=15 participants at risk A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 participants at risk A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Cardiac disorders Cardiac Arrest	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)

Other adverse events

Additional Information

Radha Korupolu, MD

The University of Texas Health Science Center at Houston

Phone: 713-797-5233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	High Tidal Volume n=15 participants at risk A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. High tidal volume: A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.	Low Tidal Volume n=15 participants at risk A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. Low tidal volume: A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Renal and urinary disorders Urinary tract infection	53.3% 8/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	40.0% 6/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Infections and infestations Sacral Wound Infection	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Vascular disorders Deep Vein Thrombosis	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Reproductive system and breast disorders Prostatitis	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Reproductive system and breast disorders Vaginal Infection	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Mucus plug, which required a transfer	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Bronchitis/Tracheitis	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Pleural effusion	40.0% 6/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	53.3% 8/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Atelectasis requiring intervention	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
General disorders COVID	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Pneumonia after 48 hours of admission	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	40.0% 6/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Respiratory, thoracic and mediastinal disorders hemoptysis	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	6.7% 1/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)
Infections and infestations Sepsis	0.00% 0/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)	13.3% 2/15 • From the time of enrollment to time of discharge from hospital (about 6 weeks)