Respiratory Distress SyndromeNCT00295230
Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants
An observational study of Respiratory Distress Syndrome, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. Read more about this study
- Who is it for?
- Ages 72 to 120 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- PSV+VG mode versus SIMV+VG mode
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Sep 2007
- Phase
- Observational
- 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 72 to 120 hours
- All sexes
- No healthy volunteers
- Child
Study population: premature infants weighing </= 1500 grams and needing mechanical ventilation at 72-120 hours of age.
Who may be able to join
- Infants will be recruited based on the following criteria: weight ≤1500 grams and need for mechanical ventilation at 72 - 120 hours of age. Recruitment will continue until 16 patients have completed the study
Who cannot join
- Exclusion criteria include significant endotracheal tube leak (>30% leak does not allow for accurate measurement of ventilator data), use of narcotic drip medication, use of paralytic medication, use of inhaled nitric oxide, fraction of inspired oxygen (FiO2) >70% at the time of enrollment, or significant congenital defects of any organ system (e.g. cardiac, respiratory, CNS).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: The Effects of Volume Guarantee Combined With Pressure Supported Ventilation (PSV+VG) Versus Synchronized Intermittent Mandatory Ventilation (SIMV+VG) in Very Low Birth Weight Infants
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. To date, only one recent study has investigated the relative advantages of combining VG with different modes of synchronized mechanical ventilation in clinically stable, preterm infants that were mechanically ventilated at an average age of one month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very low birth weight infants within the first three to five days of life. Our hypothesis is that in very low birth weight infants requiring mechanical ventilation in the first three to five days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average mean airway pressure in the PSV+VG group compared to the SIMV+VG group.
Read the detailed description
After informed consent is obtained, each patient will be started on the study between 72 to 96 hours of age. Each infant will be assigned via block randomization to an initial ventilation mode (PSV+VG or SIMV+VG). Mechanical ventilation will be provided using the Dräeger Babylog 8000Ò. Once on study, infants will receive each ventilation mode (PSV+VG and SIMV+VG) twice, administered in alternating ninety minute blocks. Ventilator management in each mode will be standardized as follows: ventilator rate of 30 breaths per minute, volume guarantee of 4-6 cc/kg, inspiratory time of 0.3-0.35 seconds, and positive end-expiratory pressure of 5-7 cmH2O. Peak inspiratory pressure (PIP) will be set at 15-20% above the PIP needed to achieve the set tidal volume. FiO2 will be maintained to keep oxygen saturation in the range of 85-96%. The FiO2 will only be adjusted if the infant's oxygen saturation is persistently outside of the target range. End tidal carbon dioxide levels will be obtained at two times (30 minutes and 90 minutes) during each study block.
No laboratory tests will be obtained for this study. However, blood gases may be obtained by the NICU care team during the study per their daily care plan, and subsequent ventilator changes may be made by the NICU care team if necessary to correct an undesired blood gas value.
All data will be obtained using the pre-existing equipment in place to care for the patient prior to this study. This equipment includes the mechanical ventilator, endotracheal tube, cardio-respiratory monitor, and blood pressure monitor.
The key measurements during this study are ventilator variables and physiologic vital signs. Ventilator variables include respiratory rate, actual PIP, mean airway pressure, FiO2, expiratory tidal volume, minute ventilation, and actual I-time. Vital signs include heart rate, oxygen saturation, and blood pressure. Ventilator variables will be continuously downloaded from the Dräeger Babylog 8000Ò using BabyviewÒ software. Heart rate and oxygen saturation data will be downloaded from the MassimoÒ pulse oximeter. Blood pressure measurements will be documented every ten minutes if the infant has an umbilical artery catheter (UAC) or percutaneous arterial line (PAL) in place. If the infant does not have an UAC or PAL in place prior to the study, blood pressure measurements will be obtained every thirty minutes via manual blood pressure cuff.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- PSV+VG mode versus SIMV+VG mode
- Keywords
- respiratory distress syndrome, very low birth weight infant, mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSV+VG mode versus SIMV+VG modeProcedure or surgery
fully assisted mechanical ventilation versus assistance on only a select number of breaths
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
Measured: 6hr
Secondary outcomes (2)
Ventilator variables
Measured: 6hr
Vital signs
Measured: 6hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionSep 2007 (estimated)
Why it stopped: suboptimal enrollment after 18 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Windtree Therapeutics
- Investigators
- Mark Mammel, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295230
- Sponsor's protocol ID
- 0512098
- Status last verified
- Nov 2007
- First submitted
- 21 Feb 2006
- Last updated
- 7 Nov 2007
- Results posted
- No
Publications
Cheema IU, Ahluwalia JS. Feasibility of tidal volume-guided ventilation in newborn infants: a randomized, crossover trial using the volume guarantee modality. Pediatrics. 2001 Jun;107(6):1323-8. doi: 10.1542/peds.107.6.1323.
PubMed 11389251Herrera CM, Gerhardt T, Claure N, Everett R, Musante G, Thomas C, Bancalari E. Effects of volume-guaranteed synchronized intermittent mandatory ventilation in preterm infants recovering from respiratory failure. Pediatrics. 2002 Sep;110(3):529-33. doi: 10.1542/peds.110.3.529.
PubMed 12205255Keszler M, Abubakar K. Volume guarantee: stability of tidal volume and incidence of hypocarbia. Pediatr Pulmonol. 2004 Sep;38(3):240-5. doi: 10.1002/ppul.20063.
PubMed 15274104Mrozek JD, Bendel-Stenzel EM, Meyers PA, Bing DR, Connett JE, Mammel MC. Randomized controlled trial of volume-targeted synchronized ventilation and conventional intermittent mandatory ventilation following initial exogenous surfactant therapy. Pediatr Pulmonol. 2000 Jan;29(1):11-8. doi: 10.1002/(sici)1099-0496(200001)29:13.0.co;2-5.
PubMed 10613781Abubakar K, Keszler M. Effect of volume guarantee combined with assist/control vs synchronized intermittent mandatory ventilation. J Perinatol. 2005 Oct;25(10):638-42. doi: 10.1038/sj.jp.7211370.
PubMed 16094389
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Volume Guarantee Combined With Pressure Supported Ventilation (PSV+VG) Versus Synchronized Intermittent Mandatory Ventilation (SIMV+VG) in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT00295230
- Acronym / sponsor ID
- 0512098
- Conditions
- Respiratory Distress Syndrome
- Keywords
- respiratory distress syndrome, very low birth weight infant, mechanical ventilation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: suboptimal enrollment after 18 months.
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- Windtree Therapeutics
- Study start
- Feb 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 23 Feb 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.
Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. To date, only one recent study has investigated the relative advantages of combining VG with different modes of synchronized mechanical ventilation in clinically stable, preterm infants that were mechanically ventilated at an average age of one month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very low birth weight infants within the first three to five days of life. Our hypothesis is that in very low birth weight infants requiring mechanical ventilation in the first three to five days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average mean airway pressure in the PSV+VG group compared to the SIMV+VG group.
Detailed description
After informed consent is obtained, each patient will be started on the study between 72 to 96 hours of age. Each infant will be assigned via block randomization to an initial ventilation mode (PSV+VG or SIMV+VG). Mechanical ventilation will be provided using the Dräeger Babylog 8000Ò. Once on study, infants will receive each ventilation mode (PSV+VG and SIMV+VG) twice, administered in alternating ninety minute blocks. Ventilator management in each mode will be standardized as follows: ventilator rate of 30 breaths per minute, volume guarantee of 4-6 cc/kg, inspiratory time of 0.3-0.35 seconds, and positive end-expiratory pressure of 5-7 cmH2O. Peak inspiratory pressure (PIP) will be set at 15-20% above the PIP needed to achieve the set tidal volume. FiO2 will be maintained to keep oxygen saturation in the range of 85-96%. The FiO2 will only be adjusted if the infant's oxygen saturation is persistently outside of the target range. End tidal carbon dioxide levels will be obtained at two times (30 minutes and 90 minutes) during each study block.
No laboratory tests will be obtained for this study. However, blood gases may be obtained by the NICU care team during the study per their daily care plan, and subsequent ventilator changes may be made by the NICU care team if necessary to correct an undesired blood gas value.
All data will be obtained using the pre-existing equipment in place to care for the patient prior to this study. This equipment includes the mechanical ventilator, endotracheal tube, cardio-respiratory monitor, and blood pressure monitor.
The key measurements during this study are ventilator variables and physiologic vital signs. Ventilator variables include respiratory rate, actual PIP, mean airway pressure, FiO2, expiratory tidal volume, minute ventilation, and actual I-time. Vital signs include heart rate, oxygen saturation, and blood pressure. Ventilator variables will be continuously downloaded from the Dräeger Babylog 8000Ò using BabyviewÒ software. Heart rate and oxygen saturation data will be downloaded from the MassimoÒ pulse oximeter. Blood pressure measurements will be documented every ten minutes if the infant has an umbilical artery catheter (UAC) or percutaneous arterial line (PAL) in place. If the infant does not have an UAC or PAL in place prior to the study, blood pressure measurements will be obtained every thirty minutes via manual blood pressure cuff.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 72 to 120 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature infants weighing </= 1500 grams and needing mechanical ventilation at 72-120 hours of age.
Key inclusion criteria (1 listed)
- Infants will be recruited based on the following criteria: weight ≤1500 grams and need for mechanical ventilation at 72 - 120 hours of age. Recruitment will continue until 16 patients have completed the study
Key exclusion criteria (1 listed)
- Exclusion criteria include significant endotracheal tube leak (>30% leak does not allow for accurate measurement of ventilator data), use of narcotic drip medication, use of paralytic medication, use of inhaled nitric oxide, fraction of inspired oxygen (FiO2) >70% at the time of enrollment, or significant congenital defects of any organ system (e.g. cardiac, respiratory, CNS).
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 |
|---|---|---|
| PSV+VG mode versus SIMV+VG modefully assisted mechanical ventilation versus assistance on only a select number of breaths | Procedure or surgery | – |
Primary outcome
Respiratory rate
Time frame: 6hr
2 secondary outcomes
Ventilator variables
Time frame: 6hr
Vital signs
Time frame: 6hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2007.
- Background: PubMed 11389251Cheema IU, Ahluwalia JS. Feasibility of tidal volume-guided ventilation in newborn infants: a randomized, crossover trial using the volume guarantee modality. Pediatrics. 2001 Jun;107(6):1323-8. doi: 10.1542/peds.107.6.1323.
- Background: PubMed 12205255Herrera CM, Gerhardt T, Claure N, Everett R, Musante G, Thomas C, Bancalari E. Effects of volume-guaranteed synchronized intermittent mandatory ventilation in preterm infants recovering from respiratory failure. Pediatrics. 2002 Sep;110(3):529-33. doi: 10.1542/peds.110.3.529.
- Background: PubMed 15274104Keszler M, Abubakar K. Volume guarantee: stability of tidal volume and incidence of hypocarbia. Pediatr Pulmonol. 2004 Sep;38(3):240-5. doi: 10.1002/ppul.20063.
- Background: PubMed 10613781Mrozek JD, Bendel-Stenzel EM, Meyers PA, Bing DR, Connett JE, Mammel MC. Randomized controlled trial of volume-targeted synchronized ventilation and conventional intermittent mandatory ventilation following initial exogenous surfactant therapy. Pediatr Pulmonol. 2000 Jan;29(1):11-8. doi: 10.1002/(sici)1099-0496(200001)29:13.0.co;2-5.
- Background: PubMed 16094389Abubakar K, Keszler M. Effect of volume guarantee combined with assist/control vs synchronized intermittent mandatory ventilation. J Perinatol. 2005 Oct;25(10):638-42. doi: 10.1038/sj.jp.7211370.
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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.
Mark Mammel, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by Children's Hospitals and Clinics of Minnesota 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 7 Nov 2007. 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?
Results are not available in the source record.
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?
Respiratory rate (time frame: 6hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295230, which also lists 5 linked publications.
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 7 Nov 2007.