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

Spinal Cord Injuries Clinical Trial

Official title:

Comparison of Mechanical Ventilation With Low and High Tidal Volumes in Acute Spinal Cord Injury: A Pilot Randomized Comparative Effectiveness Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04912583
• Other study ID #: HSC-MS-21-0222
• Secondary ID: KL2TR003168
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: This study's primary objective is to evaluate the efficacy and feasibility of mechanical ventilation with high vs. low tidal volume (Vt) in people with acute spinal cord injury (SCI). Secondary objectives include a comparison of inflammatory markers between these groups.

Study Design: Randomized comparative effectiveness trial

Methods: Study population: Adults with acute traumatic SCI on mechanical ventilation (MV). Subjects will be randomized to receive either a lower Vt of 8-10 cc/kg predicted body weight (pbw) or a high Vt of 14-16 ml/kg pbw.

Risks and potential Benefits: Risks of study interventions are similar to usual care as proposed tidal volume settings are within the current usual care range. However, people assigned to the lower tidal volume group may have a lower risk of pneumonia and respiratory complications.

Description:

Background: Respiratory complications associated with mechanical ventilation (MV) are the leading cause of morbidity and mortality following acute spinal cord injury (SCI). Emerging evidence suggests pneumonia is also associated with reduced neurologic recovery. Therefore, pneumonia prevention is of primary importance to improve outcomes. In the non-SCI population, MV with lower tidal volume (Vt) has been shown to reduce inflammation and rates of pneumonia. High Vt MV results in disruption of pulmonary endothelium and release of inflammatory mediators, which play a role in the development of pulmonary complications. In contrast, guidelines for SCI practitioners recommend MV with higher Vt without strong evidence.

Objective: The primary objective of this study is to evaluate the feasibility of conducting a randomized control trial comparing MV with high vs. low Vt. Secondary objectives include a comparison of clinical outcomes and inflammatory mediators between these groups.

Methods: Study population: Adults with acute traumatic SCI admitted to an acute inpatient rehabilitation facility on MV. Subjects will be randomized to receive either a lower Vt of 8-10 cc/kg predicted body weight (pbw) or a high Vt of 14-16 ml/kg pbw. Study participants will be randomly assigned to high tidal volume (14-16 ml/kg pbw) or low tidal volume of 8 to 10 ml/kg pbw within 48 hrs of admission, stratified based on vital capacity at admission to ensure equal allocation of those with most severe respiratory impairment and unlikely to wean from the vent.

Importance of knowledge gained from the study: Investigators believe the completion of this study will add to the fund of knowledge of respiratory management of people with SCI, especially at the early stages of the injury, including reducing respiratory complications in people with SCI who are at very high risk of severe respiratory complications which is the main cause of morbidity and mortality in this population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: June 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients = 18 years (Lung volumes and ventilator settings are different for ages <18 years).

• Acute SCI of duration = four months

• Mechanical ventilation subjects: traumatic or non-traumatic cervical SCI with neurological level C1-C5 admitted to our acute inpatient rehabilitation facility (AIR) on mechanical ventilation

Exclusion Criteria:

• Severe dysphagia due to concomitant brain stem injury, which increases the risk of pneumonia

• Severe brain injury resulting in dysphagia and inability to follow instructions to perform vital capacity measurements

• ARDS or severe lung disease (required supplemental oxygen or ventilator prior to SCI) at the time of admission (these conditions will not allow patients to randomize because target vt may below)

• Prolonged antibiotics for > 3 weeks at the time of admission due to infection (e.g., osteomyelitis, epidural abscess, etc.),

• Presence of diaphragmatic pacemaker.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Craig H. Neilsen Foundation (CNHF), National Center for Advancing Translational Sciences (NCATS), TIRR Memorial Hermann

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hatton GE, Mollett PJ, Du RE, Wei S, Korupolu R, Wade CE, Adams SD, Kao LS. High tidal volume ventilation is associated with ventilator-associated pneumonia in acute cervical spinal cord injury. J Spinal Cord Med. 2021 Sep;44(5):775-781. doi: 10.1080/10790268.2020.1722936. Epub 2020 Feb 11. — View Citation

Korupolu R, Stampas A, Uhlig-Reche H, Ciammaichella E, Mollett PJ, Achilike EC, Pedroza C. Comparing outcomes of mechanical ventilation with high vs. moderate tidal volumes in tracheostomized patients with spinal cord injury in acute inpatient rehabilitation setting: a retrospective cohort study. Spinal Cord. 2021 Jun;59(6):618-625. doi: 10.1038/s41393-020-0517-4. Epub 2020 Jul 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of respiratory complications	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.	From the time of enrollment to the time of discharge from the hospital (about 6 weeks)
Primary	Number of episodes of pneumonia	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. 21 Any new pneumonia episodes which meet the above criteria and developed 48 hrs after achieving target Vt will be recorded.	From the time of enrollment to time of discharge from hospital (about 6 weeks)
Secondary	Feasibility as assessed by recruitment rate	Recruitment rate is the proportion of eligible people who provide consent.	At the time of consent (within 48 hours of hospital admission)
Secondary	Feasibility as assessed by adherence rate	Adherence rate is the proportion of participants in each group who receive the assigned intervention per protocol.	At the time of start of intervention (within 48 hours of hospital admission)
Secondary	Feasibility as assessed by retention rate	Retention rate is the proportion of participants in each group who complete all study procedures.	at the time of discharge from hospital (6 weeks)