ExtubationNAVANCT00814853
Electrical Activity of the Diaphragm During Extubation Readiness Testing
An observational study of Extubation, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during respiration, is measured. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Extubation
- What is being tested?
- NAVA (Extubation readiness testing failures)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2010
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Anyone eligible for and extubation readiness test.
Who may be able to join
- All intubated and mechanically ventilated patients age 1 month to 18 years and meeting the extubation readiness criterion.
Who cannot join
- Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Boston
Boston, Massachusetts, 02115
Brian K Walsh, BS, MBA, RRT, 617-935-7885, brian.walsh@childrens.harvard.edu
Gerhard Wolf, MD
About this study
Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during respiration, is measured. The ventilator applies support in proportion to the measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it.
Whenever a patient gets extubated in our MSICU, we conduct a routine extubation readiness test. This is standard of care in our ICU. If the patient fails this test, the patient stays on the ventilator. If he passes, he gets extubated. We wish to conduct a study during which we will monitor the electrical activity of the diaphragm during this test. If the patient passes the extubation readiness test, the study is complete. If he fails, he resumes on the ventilator. In our study, we would then use the measured signal of the diaphragm to guide the ventilator. This mode of ventilation is called NAVA. We do not currently use this mode of ventilation in the ICU, but could do so since it is FDA approved. However, we wish to use this protocol to gain more expertise with this mode of ventilation in the ICU in a controlled fashion. We wish to enroll 20 pediatric patients. Patients in the ICU are routinely on a variety of different models of ventilators. Usually, the respiratory therapist determines which ventilator will be used. All patients in this study would be on the Servo-I ventilator, which is an FDA approved ventilator and capable of monitoring electrical activity of the diaphragm and currently used in our MSICU.
Read the detailed description
- Specific Aims /Objectives Specific Aim 1: To determine if Edi is a predictor of extubation readiness. (Hypothesis: an increase of 20-50% in Edi from baseline (prior to ERT) will predict successful extubation.) Specific Aim 2: If the patient fails the ERT - We hope to determine if NAVA will provide more information about why the patient failed the ERT. (Hypothesis: a decrease in peak inspiratory pressure from baseline (post ERT failure) is predictive of high frequency diaphragm fatigue and subsequent successful ERT.
- Background and Significance The diaphragmatic function plays a pivotal role in the patient's ability to breathe on a ventilator, and on the successfulness of weaning from a ventilator and extubation. However, diaphragmatic function is not routinely measured in the ICU, which we would like to do in this trial. When the mechanical load of the respiratory system is too large or continues for a long period of time, the diaphragm can develop contractile fatigue[1]. This fatigue can be short or long term. Short term is also known as high-frequency fatigue that results from the accumulation of inorganic phosphate[2][3], and to a lesser extent intramuscular acidosis[4]. On the other hand long term fatigue, otherwise known as low-frequency fatigue is consistent with muscle injury[5, 6] and can persist for days. Being able to identify what type of diaphragm fatigue is present could help us understand the patient's readiness to be extubated. Despite the frequent use of mechanical ventilation, determining when to appropriately discontinue mechanical ventilation and extubate a patient remains a challenge. Many weaning protocols exist but are typically extrapolated from adult studies. These protocols can consist of but are not limited to use sprint weaning utilizing a T-piece (no support, just oxygen), continuous positive airway pressure (CPAP) or pressure support (PSV) trail. Usually, data is gathered through spirometry with a ventilator (shallow breathing index, tidal volumes, etc.) and vital signs are recorded [7, 8]. Despite the use of protocols extubation failure range from 15-24% (Randolph) in the pediatric population. Investigators have explored physiological evidence of improving lung function to help determine the appropriate time to discontinue mechanical ventilation. One notable effort by Hubble et al was to obtain dead space to tidal volume ratio (Vd/Vt) to determine extubation success after a 30 minute PSV trail prior to extubation[9]. They concluded that a Vd/Vt ratio of less than or equal to 0.5 reliably predicted successful extubation (96%). However, this only provides one part of the equation - lung function- but not necessarily the central nervous system interaction or the work of breathing associated. Currently, the MSICU uses an extubation readiness test (ERT). This test determines if patients are eligible for discontinuation of mechanical ventilation. This test consist of a daily screen of changing the FIO2 (fraction of inspired oxygen) to 50% (left at current setting if lower than 50%) and decrease the PEEP to 5 cmH2O. Patients unable to maintain saturation (SpO2) of 95%, or become tachypneic, or appear uncomfortable failed the test; those who maintained SpO2 of 95% or higher have their mode of ventilation changed to minimal pressure support (PSV). Minimal PSV was determined by the endotracheal tube (ETT) size. Patients were classified as failing the test if at any time in the two hour period their SpO2 was less than 95%, their exhaled tidal volume was less than 5 mL/kg ideal body weight, or their respiratory rate was outside of the acceptable range for age. If the patient fails an ERT they are returned to their previous ventilator setting and evaluated for extubation readiness in 24 hours. It is understood that sedation is one of the primary caused of extubation failure, however there is additional concern regarding the diaphragmatic function. When the mechanical load of the respiratory system is too large or continues for a long period of time, the diaphragm can develop contractile fatigue[4]. This fatigue can be short or long term. Short term is also known as high-frequency fatigue that results from the accumulation of inorganic phosphate[5], failure of the membrane electrical potential[6], and to a lesser extent intramuscular acidosis[7], but recover quickly. On the other hand long term fatigue, otherwise known as low-frequency fatigue is consistent with muscle injury [8, 9] and can persist for days. Being able to identify what type of diaphragm fatigue could lead us to hold on extubation readiness testing as to not re-injury. When patients are extubated too early, respiratory failure can occur [10, 11]. When extubation is delayed, lengths of time on mechanical ventilation and in the ICU stay both increases. This leads to additional respiratory complications such as ventilator associated pneumonia and overall lung damage[12]. Thus, the decision to extubate should be made on the basis of accurate, objective and reproducible criteria. The diaphragmatic activity is likely one of those criteria that are not yet measured. We aim to add some additional information to this body of knowledge that may link the respiratory pump (diaphragm) to lung function, muscle fatigue, and/or central nervous system depression.
- Preliminary Studies/Progress Report To our knowledge there is not previous data determining if Edi can predict extubation success. However, there are a few limited studies on low and high-frequency diaphragm fatigue in adults and animals. Dr. Laghi and colleagues carefully examined 11 who failed extubation and eight adults whom successfully weaned from mechanical ventilation. They concluded that weaning itself did not cause low-frequency fatigue [13]. While Edi was examined in six health adults at high frequency fatigue levels. Edi was found to successfully assess neural drive and that diaphragm fatigue did not affect respiratory drive. Limits to the studies mentioned above that we plan to address are: none were done in children with highly resistive endotracheal tubes, length of mechanical ventilation was not examined (low vs. high frequency diaphragm fatigue risk), there was no formal ERT, and examination of low and high frequency diaphragm fatigue in the same patient population was not done.
- Design and Methods a. Study Design In a prospective, blinded (Edi information blinded to the team) clinical trail we will study the diaphragmatic activity that occur prior and following our standard extubation readiness test (minimum pressure support trial). We will examine that diaphragmatic activity by examining the Edi prior to, during, and post the trial on every patient who qualifies. Furthermore, patients who fail ERT will be ventilated with the NAVA mode of ventilation. The entire protocol will be conducted on the Maquet Servo I ventilator
- Conditions
- Extubation
- Being tested
- NAVA (Extubation readiness testing failures)
- Keywords
- Extubation, testing, ventilator weaning, Pediatric extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA (Extubation readiness testing failures)Device
Patients who fail the ERT will be place in the mode of ventilation NAVA.
| Study group | Role | What they receive |
|---|---|---|
| Extubation readiness testing | Patients who pass the ERT. Receives: Device: NAVA (Extubation readiness testing failures) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDI pre and post extubation readiness testing.
Measured: 2 hours
Secondary outcomes (1)
Will the mode of ventilation NAVA wean the patient back to ERT settings.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Wolf, MD, Principal investigator, Children's Hospital Boston, Harvard Medical SchoolBrian K Walsh, BS, RRT-NPS, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814853
- Sponsor's protocol ID
- 08-07-0338
- Other IDs
- ERT
- Acronym
- NAVA
- Status last verified
- Aug 2009
- First submitted
- 24 Dec 2008
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Activity of the Diaphragm During Extubation Readiness Testing
- ClinicalTrials.gov ID
- NCT00814853
- Acronym / sponsor ID
- NAVA / 08-07-0338
- Conditions
- Extubation
- Keywords
- Extubation, testing, ventilator weaning, Pediatric extubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Dec 2008 (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.
Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during respiration, is measured. The ventilator applies support in proportion to the measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it.
Whenever a patient gets extubated in our MSICU, we conduct a routine extubation readiness test. This is standard of care in our ICU. If the patient fails this test, the patient stays on the ventilator. If he passes, he gets extubated. We wish to conduct a study during which we will monitor the electrical activity of the diaphragm during this test. If the patient passes the extubation readiness test, the study is complete. If he fails, he resumes on the ventilator. In our study, we would then use the measured signal of the diaphragm to guide the ventilator. This mode of ventilation is called NAVA. We do not currently use this mode of ventilation in the ICU, but could do so since it is FDA approved. However, we wish to use this protocol to gain more expertise with this mode of ventilation in the ICU in a controlled fashion. We wish to enroll 20 pediatric patients. Patients in the ICU are routinely on a variety of different models of ventilators. Usually, the respiratory therapist determines which ventilator will be used. All patients in this study would be on the Servo-I ventilator, which is an FDA approved ventilator and capable of monitoring electrical activity of the diaphragm and currently used in our MSICU.
Detailed description
- Specific Aims /Objectives Specific Aim 1: To determine if Edi is a predictor of extubation readiness. (Hypothesis: an increase of 20-50% in Edi from baseline (prior to ERT) will predict successful extubation.) Specific Aim 2: If the patient fails the ERT - We hope to determine if NAVA will provide more information about why the patient failed the ERT. (Hypothesis: a decrease in peak inspiratory pressure from baseline (post ERT failure) is predictive of high frequency diaphragm fatigue and subsequent successful ERT.
- Background and Significance The diaphragmatic function plays a pivotal role in the patient's ability to breathe on a ventilator, and on the successfulness of weaning from a ventilator and extubation. However, diaphragmatic function is not routinely measured in the ICU, which we would like to do in this trial. When the mechanical load of the respiratory system is too large or continues for a long period of time, the diaphragm can develop contractile fatigue[1]. This fatigue can be short or long term. Short term is also known as high-frequency fatigue that results from the accumulation of inorganic phosphate[2][3], and to a lesser extent intramuscular acidosis[4]. On the other hand long term fatigue, otherwise known as low-frequency fatigue is consistent with muscle injury[5, 6] and can persist for days. Being able to identify what type of diaphragm fatigue is present could help us understand the patient's readiness to be extubated. Despite the frequent use of mechanical ventilation, determining when to appropriately discontinue mechanical ventilation and extubate a patient remains a challenge. Many weaning protocols exist but are typically extrapolated from adult studies. These protocols can consist of but are not limited to use sprint weaning utilizing a T-piece (no support, just oxygen), continuous positive airway pressure (CPAP) or pressure support (PSV) trail. Usually, data is gathered through spirometry with a ventilator (shallow breathing index, tidal volumes, etc.) and vital signs are recorded [7, 8]. Despite the use of protocols extubation failure range from 15-24% (Randolph) in the pediatric population. Investigators have explored physiological evidence of improving lung function to help determine the appropriate time to discontinue mechanical ventilation. One notable effort by Hubble et al was to obtain dead space to tidal volume ratio (Vd/Vt) to determine extubation success after a 30 minute PSV trail prior to extubation[9]. They concluded that a Vd/Vt ratio of less than or equal to 0.5 reliably predicted successful extubation (96%). However, this only provides one part of the equation - lung function- but not necessarily the central nervous system interaction or the work of breathing associated. Currently, the MSICU uses an extubation readiness test (ERT). This test determines if patients are eligible for discontinuation of mechanical ventilation. This test consist of a daily screen of changing the FIO2 (fraction of inspired oxygen) to 50% (left at current setting if lower than 50%) and decrease the PEEP to 5 cmH2O. Patients unable to maintain saturation (SpO2) of 95%, or become tachypneic, or appear uncomfortable failed the test; those who maintained SpO2 of 95% or higher have their mode of ventilation changed to minimal pressure support (PSV). Minimal PSV was determined by the endotracheal tube (ETT) size. Patients were classified as failing the test if at any time in the two hour period their SpO2 was less than 95%, their exhaled tidal volume was less than 5 mL/kg ideal body weight, or their respiratory rate was outside of the acceptable range for age. If the patient fails an ERT they are returned to their previous ventilator setting and evaluated for extubation readiness in 24 hours. It is understood that sedation is one of the primary caused of extubation failure, however there is additional concern regarding the diaphragmatic function. When the mechanical load of the respiratory system is too large or continues for a long period of time, the diaphragm can develop contractile fatigue[4]. This fatigue can be short or long term. Short term is also known as high-frequency fatigue that results from the accumulation of inorganic phosphate[5], failure of the membrane electrical potential[6], and to a lesser extent intramuscular acidosis[7], but recover quickly. On the other hand long term fatigue, otherwise known as low-frequency fatigue is consistent with muscle injury [8, 9] and can persist for days. Being able to identify what type of diaphragm fatigue could lead us to hold on extubation readiness testing as to not re-injury. When patients are extubated too early, respiratory failure can occur [10, 11]. When extubation is delayed, lengths of time on mechanical ventilation and in the ICU stay both increases. This leads to additional respiratory complications such as ventilator associated pneumonia and overall lung damage[12]. Thus, the decision to extubate should be made on the basis of accurate, objective and reproducible criteria. The diaphragmatic activity is likely one of those criteria that are not yet measured. We aim to add some additional information to this body of knowledge that may link the respiratory pump (diaphragm) to lung function, muscle fatigue, and/or central nervous system depression.
- Preliminary Studies/Progress Report To our knowledge there is not previous data determining if Edi can predict extubation success. However, there are a few limited studies on low and high-frequency diaphragm fatigue in adults and animals. Dr. Laghi and colleagues carefully examined 11 who failed extubation and eight adults whom successfully weaned from mechanical ventilation. They concluded that weaning itself did not cause low-frequency fatigue [13]. While Edi was examined in six health adults at high frequency fatigue levels. Edi was found to successfully assess neural drive and that diaphragm fatigue did not affect respiratory drive. Limits to the studies mentioned above that we plan to address are: none were done in children with highly resistive endotracheal tubes, length of mechanical ventilation was not examined (low vs. high frequency diaphragm fatigue risk), there was no formal ERT, and examination of low and high frequency diaphragm fatigue in the same patient population was not done.
- Design and Methods a. Study Design In a prospective, blinded (Edi information blinded to the team) clinical trail we will study the diaphragmatic activity that occur prior and following our standard extubation readiness test (minimum pressure support trial). We will examine that diaphragmatic activity by examining the Edi prior to, during, and post the trial on every patient who qualifies. Furthermore, patients who fail ERT will be ventilated with the NAVA mode of ventilation. The entire protocol will be conducted on the Maquet Servo I ventilator
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extubation readiness testing | – | Device: NAVA (Extubation readiness testing failures)Patients who pass the ERT. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Anyone eligible for and extubation readiness test.
Key inclusion criteria (1 listed)
- All intubated and mechanically ventilated patients age 1 month to 18 years and meeting the extubation readiness criterion.
Key exclusion criteria (1 listed)
- Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.
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 |
|---|---|---|
| NAVA (Extubation readiness testing failures)Patients who fail the ERT will be place in the mode of ventilation NAVA. | Device | Extubation readiness testing |
Primary outcome
EDI pre and post extubation readiness testing.
Time frame: 2 hours
1 secondary outcome
Will the mode of ventilation NAVA wean the patient back to ERT settings.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
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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.
Gerhard Wolf, MD principal investigator
Children's Hospital Boston, Harvard Medical School
Brian K Walsh, BS, RRT-NPS principal investigator
Boston Children's Hospital
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 Extubation, run by Boston Children's 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 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: status not confirmed, as of the sponsor's last update on 4 Aug 2009. 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?
Contact Brian K Walsh, BS, MBA, RRT-NPS (617-935-7885, brian.walsh@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDI pre and post extubation readiness testing. (time frame: 2 hours). 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 4 Aug 2009.