Respiratory FailureVIDDNCT03768232
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)
An observational study of Respiratory Failure and Respiratory Distress Syndrome, run by Bambino Gesù Hospital and Research Institute.
Trial summary
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Respiratory Failure, Respiratory Distress Syndrome, Mechanical Ventilation Complication
- What is being tested?
- ultrasound asessment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jan 2020
- 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all patient admitted in PICU
Who may be able to join
- patients younger than 18 years old
- expected clinical requiring of invasive MV for more than 36 hours
Who cannot join
- neonates
- subjects with preexisting diagnoses of neuromuscular weakness
- diaphragm paresis
- chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.
About this study
Official title: Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy
Read the detailed description
Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.
Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.
Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.
- Being tested
- ultrasound asessment
- Keywords
- ultrasound assessment, diaphragm disfuncion
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound asessmentOther
US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient
the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology
Measured: through study completion an average of 100 days
Secondary outcomes (3)
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
evaluation of the impact of VIDD and clinical outcomes of our patients in terms of Mechanical Ventilation free days
Measured: through study completion an average of 100 days
evaluation of two different diaphragmatic thickening fraction formula (DTF)
evaluate the feasibility and clinical applicability of our formula for the calculation of DTF (mTdi-insp - mTdi-exp)/mTdi-med x 100, comparing it to the standard one (Tdi-insp - Tdi-exp)/Tdi-exp x 100.
Measured: through study completion an average of 100 days
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
evaluation of the impact of VIDD and clinical outcomes of our patients, in terms of MV free days, PICU length of stay (LOS) - days
Measured: through study completion an average of 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Di Nardo, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768232
- Sponsor's protocol ID
- 001
- Acronym
- VIDD
- Status last verified
- Dec 2018
- First submitted
- 14 Nov 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
PubMed 23641946Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
PubMed 21705883Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
PubMed 18367735Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.
PubMed 26724302Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.
PubMed 29406380Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PubMed 28930478
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03768232
- Acronym / sponsor ID
- VIDD / 001
- Keywords
- ultrasound assessment, diaphragm disfuncion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 7 Dec 2018 (actual)
- 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.
evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy
Detailed description
Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.
Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.
Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patient admitted in PICU
Key inclusion criteria (2 listed)
- patients younger than 18 years old
- expected clinical requiring of invasive MV for more than 36 hours
Key exclusion criteria (4 listed)
- neonates
- subjects with preexisting diagnoses of neuromuscular weakness
- diaphragm paresis
- chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.
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 |
|---|---|---|
| ultrasound asessmentUS diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation. | Other | – |
Primary outcome
measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient
Time frame: through study completion an average of 100 days
the assessment of the actual occurrence rate of VIDD in a population of PICU patients undergoing MV for acute respiratory failure of various etiology
3 secondary outcomes
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
Time frame: through study completion an average of 100 days
evaluation of two different diaphragmatic thickening fraction formula (DTF)
Time frame: through study completion an average of 100 days
evaluation clinical impact of ventilator induced diaphragm disfunction in pediatric patient
Time frame: through study completion an average of 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Results publication: PubMed 23641946Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.
- Results publication: PubMed 21705883Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.
- Results publication: PubMed 18367735Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.
- Results publication: PubMed 26724302Francis CA, Hoffer JA, Reynolds S. Ultrasonographic Evaluation of Diaphragm Thickness During Mechanical Ventilation in Intensive Care Patients. Am J Crit Care. 2016 Jan;25(1):e1-8. doi: 10.4037/ajcc2016563.
- Results publication: PubMed 29406380Glau CL, Conlon TW, Himebauch AS, Yehya N, Weiss SL, Berg RA, Nishisaki A. Progressive Diaphragm Atrophy in Pediatric Acute Respiratory Failure. Pediatr Crit Care Med. 2018 May;19(5):406-411. doi: 10.1097/PCC.0000000000001485.
- Results publication: PubMed 28930478Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Respiratory Distress Syndrome, run by Bambino Gesù Hospital and Research Institute.
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 2 inclusion and 4 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
measurement of occurrence rate of ventilator induced diaphragm disfunction in pediatric patient (time frame: through study completion an average of 100 days). 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 NCT03768232, which also lists 6 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 Dec 2018.