Spinal Cord InjuryNCT00412308
A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Cervical Spinal Cord Injuries
A study testing Tidal volume used in mechanical ventilation in people with Spinal Cord Injury and Respiratory Insufficiency, run by Craig Hospital at 1 site in United States.
Trial summary
The study will compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical ventilator support. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injury, Respiratory Insufficiency
- What is being tested?
- Tidal volume used in mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Traumatic SCI at levels C3 through C6, ASIA A, B, or C tetraplegia
- Subacute admission to Craig Hospital between 2 weeks and 6 months post-injury
- Completely ventilator-dependent (24 hours a day) at the time of admission to Craig Hospital
- Age 18-55 years
- Informed consent obtained
Who cannot join
- Concurrent severe traumatic brain injury resulting in inability to cooperate with wean protocol
- Residual severe chest trauma (pneumothorax, recurrent pleural effusion > one third hemithorax, indwelling chest tubes, flail chest, trapped lung, bilateral pulmonary contusions)
- Residual esophageal trauma that may cause ongoing aspiration;
- Current ARDS
- Current VAP unresponsive to antibiotic therapy
- Premorbid cardiomyopathy with ejection fraction <30%, unstable angina, bullous emphysema, obstructive lung disease with forced expiratory volume < 50% predicted, morbid obesity with BMI ≥ 35, increased intracranial pressure, neuromuscular disease, chronic liver disease Child-Pugh Class C, or history of bone marrow or solid organ transplantation
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- Critical illness polyneuropathy
- Burns over more than 30 percent of their body-surface area
- Current participation in another clinical trial
- Any condition that, in the judgment of the investigator, precludes successful participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Sub-Acute Cervical Spinal Cord Injuries
The study will compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical ventilator support.
Read the detailed description
While respiratory failure in people with SCI is common, clinicians have not come to a consensus on the best strategy to manage the mechanical ventilation of these individuals or whether to manage people with SCI differently from other patients. The Consortium for Spinal Cord Medicine has developed Clinical Practice Guidelines using protocols established at Craig Hospital in the 1980s and 1990s, but these are based only on clinical experience and retrospective, cohort data using historical controls.
These guidelines suggest that patients should be ventilated with tidal volumes (VT)of 20-25 cc/kg of ideal body weight (IBW). This recommended VT is at least twice as large as conventional VT used for general medical and surgical patients requiring mechanical ventilation. However, there is a clinical belief that people with SCI should be ventilated at higher VT to prevent atelectasis, to decrease the risk of pneumonia, and to facilitate weaning. This belief was fostered by a retrospective, concurrent cohort comparison study of individuals with SCI, which found that the use of high VT on the ventilator (mean 25.3 cc/kg, PAP<40) was associated with more rapid resolution of atelectasis and more rapid weaning from mechanical ventilation than the use of low VT (mean 15.5). Therefore, people with SCI have been clinically managed using high VT for the past 2-3 decades without prospective data to confirm these clinical impressions.
At the same time that these ventilator strategies evolved in the care of patients with SCI, several clinical studies in general medical and surgical patients requiring mechanical ventilation suggested that high VT leading to higher airway pressures could actually promote lung injury. This occurred when higher VT increased the risk of over-distending the airways and creating volume-related trauma.16-19 In multiple studies, VT of only 10-15 cc/kg IBW was found to produce alveolar over-distention, stretch injury and barotrauma. This work led to the belief that low VT of 6-8 cc/kg IBW could be helpful in protecting mechanically ventilated individuals from ventilator-induced lung injury.
Whether these findings and recommendations apply to individuals with SCI requiring mechanical ventilation is unclear. At least one study of mechanically ventilated individuals without acute respiratory distress syndrome suggests that the use of low VT (6 cc/kg) increases the risk of atelectasis.
With the lack of prospective, evidence-based data regarding optimal VT for persons with a SCI who are ventilator-dependent, clinicians may be inclined to use lower VT to prevent lung injury, unless there is more definitive data to show that higher volumes are as safe as low VT and that higher VT facilitate more rapid weaning from mechanical ventilation.
This is a prospective randomized, controlled study to compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) tidal volume (VT) vs. low (10 cc/kg) VT during mechanical ventilator support. While the use of lower tidal volumes in the general pulmonary community is more common, we and others in the SCI rehabilitation community have used 20 cc/kg IBW tidal volumes or higher to manage and attempt to wean individuals with SCI on mechanical ventilation. This study will address the safety and efficacy of using higher VT in ventilator weaning. A series of objective measures and standardized protocols are implemented to ensure equivalent pulmonary management and weaning processes in individuals, regardless of their randomization status.
- For individuals with sub-acute ventilator-dependent tetraplegia, providing high tidal volumes (VT = 20 cc/kg) will result in more rapid weaning from mechanical ventilation than use of low tidal volumes (VT = 10 cc/kg) in an 8-week trial.
- For these individuals, use of high tidal volumes will result in fewer episodes of atelectasis and ventilator acquired pneumonia (VAP) compared to use of low tidal volumes.
- There will be no difference in the incidence of a) barotrauma or b) ARDS between those using high tidal volumes compared to those using low tidal volumes.
- Conditions
- Spinal Cord Injury, Respiratory Insufficiency
- Being tested
- Tidal volume used in mechanical ventilation
- Keywords
- spinal cord injury, ventilator dependency, ventilator weaning, tidal volume
- Medical subject headings
- Spinal Cord Injuries, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume used in mechanical ventilationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full weaning from ventilator
Episodes of atelectasis
Episodes of ventilator-acquired pneumonia
Episodes of barotrauma
Episodes of acute respiratory distress syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mary Warner, MD, Principal investigator, South Denver Pulmonary Associates PCJames Fenton, MD, Principal investigator, South Denver Pulmonary Associates, PCDaniel P Lammertse, MD, Principal investigator, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412308
- Sponsor's protocol ID
- H133N060005
- Status last verified
- Jun 2011
- First submitted
- 14 Dec 2006
- Last updated
- 28 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Sub-Acute Cervical Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT00412308
- Acronym / sponsor ID
- H133N060005
- Conditions
- Spinal Cord Injury, Respiratory Insufficiency
- Keywords
- spinal cord injury, ventilator dependency, ventilator weaning, tidal volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical ventilator support.
Detailed description
While respiratory failure in people with SCI is common, clinicians have not come to a consensus on the best strategy to manage the mechanical ventilation of these individuals or whether to manage people with SCI differently from other patients. The Consortium for Spinal Cord Medicine has developed Clinical Practice Guidelines using protocols established at Craig Hospital in the 1980s and 1990s, but these are based only on clinical experience and retrospective, cohort data using historical controls.
These guidelines suggest that patients should be ventilated with tidal volumes (VT)of 20-25 cc/kg of ideal body weight (IBW). This recommended VT is at least twice as large as conventional VT used for general medical and surgical patients requiring mechanical ventilation. However, there is a clinical belief that people with SCI should be ventilated at higher VT to prevent atelectasis, to decrease the risk of pneumonia, and to facilitate weaning. This belief was fostered by a retrospective, concurrent cohort comparison study of individuals with SCI, which found that the use of high VT on the ventilator (mean 25.3 cc/kg, PAP<40) was associated with more rapid resolution of atelectasis and more rapid weaning from mechanical ventilation than the use of low VT (mean 15.5). Therefore, people with SCI have been clinically managed using high VT for the past 2-3 decades without prospective data to confirm these clinical impressions.
At the same time that these ventilator strategies evolved in the care of patients with SCI, several clinical studies in general medical and surgical patients requiring mechanical ventilation suggested that high VT leading to higher airway pressures could actually promote lung injury. This occurred when higher VT increased the risk of over-distending the airways and creating volume-related trauma.16-19 In multiple studies, VT of only 10-15 cc/kg IBW was found to produce alveolar over-distention, stretch injury and barotrauma. This work led to the belief that low VT of 6-8 cc/kg IBW could be helpful in protecting mechanically ventilated individuals from ventilator-induced lung injury.
Whether these findings and recommendations apply to individuals with SCI requiring mechanical ventilation is unclear. At least one study of mechanically ventilated individuals without acute respiratory distress syndrome suggests that the use of low VT (6 cc/kg) increases the risk of atelectasis.
With the lack of prospective, evidence-based data regarding optimal VT for persons with a SCI who are ventilator-dependent, clinicians may be inclined to use lower VT to prevent lung injury, unless there is more definitive data to show that higher volumes are as safe as low VT and that higher VT facilitate more rapid weaning from mechanical ventilation.
This is a prospective randomized, controlled study to compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) tidal volume (VT) vs. low (10 cc/kg) VT during mechanical ventilator support. While the use of lower tidal volumes in the general pulmonary community is more common, we and others in the SCI rehabilitation community have used 20 cc/kg IBW tidal volumes or higher to manage and attempt to wean individuals with SCI on mechanical ventilation. This study will address the safety and efficacy of using higher VT in ventilator weaning. A series of objective measures and standardized protocols are implemented to ensure equivalent pulmonary management and weaning processes in individuals, regardless of their randomization status.
- For individuals with sub-acute ventilator-dependent tetraplegia, providing high tidal volumes (VT = 20 cc/kg) will result in more rapid weaning from mechanical ventilation than use of low tidal volumes (VT = 10 cc/kg) in an 8-week trial.
- For these individuals, use of high tidal volumes will result in fewer episodes of atelectasis and ventilator acquired pneumonia (VAP) compared to use of low tidal volumes.
- There will be no difference in the incidence of a) barotrauma or b) ARDS between those using high tidal volumes compared to those using low tidal volumes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Traumatic SCI at levels C3 through C6, ASIA A, B, or C tetraplegia
- Subacute admission to Craig Hospital between 2 weeks and 6 months post-injury
- Completely ventilator-dependent (24 hours a day) at the time of admission to Craig Hospital
- Age 18-55 years
- Informed consent obtained
Key exclusion criteria (10 listed)
- Concurrent severe traumatic brain injury resulting in inability to cooperate with wean protocol
- Residual severe chest trauma (pneumothorax, recurrent pleural effusion > one third hemithorax, indwelling chest tubes, flail chest, trapped lung, bilateral pulmonary contusions)
- Residual esophageal trauma that may cause ongoing aspiration;
- Current ARDS
- Current VAP unresponsive to antibiotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tidal volume used in mechanical ventilation | Procedure or surgery | – |
Primary outcome
Time to full weaning from ventilator
Episodes of atelectasis
Episodes of ventilator-acquired pneumonia
Episodes of barotrauma
Episodes of acute respiratory distress syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Warner, MD principal investigator
South Denver Pulmonary Associates PC
James Fenton, MD principal investigator
South Denver Pulmonary Associates, PC
Daniel P Lammertse, MD principal investigator
Craig Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal volume used in mechanical ventilation in people with Spinal Cord Injury and Respiratory Insufficiency, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to full weaning from ventilator. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.