Preterm InfantCO-PAPNCT02528851
Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants
A study testing Extubation from endotracheal mechanical ventilation to CPAP in people with Preterm Infant, run by McMaster University.
Trial summary
The aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Extubation from endotracheal mechanical ventilation to CPAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jun 2016
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm infants less than 37 weeks of gestation who are mechanically ventilated with Endotracheal Airway Pressure (EAP) ≥ 8 cm H2O at time of extubation as per the medical team.
- Note: The decision to extubate a subject, and EAP at time of extubation, will solely be that of the medical team, and is in no way dictated by the study protocol.
Who cannot join
- Infants on EMV with EAP> 11 cmH2O at the time of extubation
- Congenital or acquired abnormality of upper airway
- Major gastrointestinal disorder or complication
- Suspected/proven chromosomal/genetic abnormality
- Suspected/confirmed sepsis being treated at time of extubation
- Unresolved hemodynamically significant patent ductus arteriosus (with or without inotropic support) at time of extubation
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- Congenital structural heart diseases
- Infants requiring vasopressor and/or inotropic support at time of extubation
- Persistent pulmonary hypertension requiring treatment with vasopressors/inhaled nitric oxide/sildenafil at time of extubation
- Any unplanned extubation in infants otherwise meeting the inclusion criteria.
Trial locations and contacts
No sites are listed yet.
Amit Mukerji, MD contact
About this study
Official title: Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High Endotracheal Airway Pressures in Preterm Infants: A Randomized Cross-Over Trial
The aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on conventional ventilation] at time of extubation. Participants will be randomized to "higher" CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We hypothesize that "higher" CPAP levels, when compared to "equivalent" CPAP levels, do not adversely impact the cardiorespiratory status when a patient is extubated from high EAP.
Read the detailed description
Extubation readiness of the enrolled infants will be determined solely by and at the discretion of the medical team. All enrolled infants will be checked to re-confirm eligibility prior to extubation. Those enrolled infants who are ventilated on EMV (endotracheal mechanical ventilation) with an airway pressure of 8-11 cm H2O at the time when they are deemed extubation-ready by the team will be eligible for randomization. Once eligibility for randomization is assessed, the study coordinator will notify the research team who will immediately perform a bedside functional echocardiography to assess cardiac output and PDA (patent ductus arteriosus) status. In addition, the lung compliance (as measured by the ventilator) will be recorded. If a PDA exists and is found to be hemodynamically significant, then the infant meets one of the exclusion criteria and will be ineligible for randomization.
Once eligibility is confirmed, infants will be randomized using sequentially numbered sealed opaque envelopes. The sequence of the randomization will be pre-determined using a computer generated algorithm, and sealed envelopes will be created by study coordinator. Once randomized, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation.
After ensuring that the infants are stable for one hour (based on pre-defined clinical instability criteria) cardiac output will be measured using bedside functional echocardiography by members of the research team blinded to the allocation. To ensure blinding the research coordinator will cover the relevant digital display of the ventilator/CPAP machine (with opaque craft paper and tape) immediately prior to the echocardiography. Other aforementioned outcomes will be recorded by the blinded investigator using standardized data collection forms. Once all outcome data are collected, the infants will cross-over to the opposite arm of the trial and a similar assessment protocol will be followed after one hour. The study protocol will be considered completed when the second set of measurements is obtained and further respiratory management will be guided by the medical team.
SAFETY ASSURANCE At any point during the study, emergence of any one of the clinical instability criteria will prompt the nursing staff to notify the medical team who would immediately assess the infant. If the infant shows signs of clinical instability the medical team will evaluate the infants' clinical condition as per a pre-defined checklist. When all the troubleshooting points mentioned in the checklist are addressed by the medical team and the infant is deemed clinically unstable, the infant would be immediately removed from the study protocol and parents of the subject will be notified. To ensure that no other factor affects the hemodynamic status of the infants during the study, the total fluid intake would remain the same and no caffeine citrate would be administered during the period of pre and post extubation assessment of cardiac output.
- Conditions
- Preterm Infant
- Being tested
- Extubation from endotracheal mechanical ventilation to CPAP
- Keywords
- CPAP, preterm, cardiac output
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation from endotracheal mechanical ventilation to CPAPProcedure or surgery
Following randomization, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation.
| Study group | Role | What they receive |
|---|---|---|
| Higher CPAP | Experimental | Infants extubated to CPAP level 2cm H2O higher than extubation EAP Receives: Procedure: Extubation from endotracheal mechanical ventilation to CPAP |
| Equivalent CPAP | Active comparator | Infants extubated to CPAP equivalent to extubation EAP Receives: Procedure: Extubation from endotracheal mechanical ventilation to CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular output
We will use the formula LVO = [LV Outflow Tract (LVOT) area x Quantity of blood across LVOT x heart rate]/body weight (ml/kg/min). The details of measurement of each component of the equation are as follows:
- LVOT area = π (LV outflow tract diameter/2)2. LV outflow tract diameter will be measured in the parasternal long axis in late systole immediately distal to the valve orifice using the leading edge technique.
- Quantity of blood across the LVOT: To be measured using the VTI (velocity time integral) from pulsed Doppler echocardiography from the modified apical view (5-chamber view)
Measured: One hour after each intervention
Secondary outcomes (7)
Heart rate
Measured: One hour after each intervention
Blood pressure
non-invasive cuff blood pressure
Measured: One hour after each intervention
abdominal wall girth
measured using a tape measure at the level of the umbilicus
Measured: One hour after each intervention
Silverman-Andersen respiratory score
Measured: One hour after each intervention
Lung compliance
Dynamic compliance would be noted from the ventilator control panel (defined as change in volume per unit change in pressure)
Measured: Pre-extubation measurement in all recruited infants
Inferior vena caval diameter
Using functional echocardiography mean inferior vena caval diameter will be measured. Mean inferior vena cava diameter (IVCD), expressed as[(IVCD in inspiration + IVCD in expiration)/2]
Measured: One hour after each intervention
Superior vena caval flow
We will use the formula SVC flow = [Mean SVC area x Quantity of blood across SVC x heart rate]/body weight (ml/kg/min).
- Mean SVC area = π (Mean SVC diameter /2)2. Mean SVC diameter will be measured in the parasternal long axis with the beam in a true sagittal plane and angled to the right of the ascending aorta. The mean of the maximum and minimum internal diameters will be taken for flow measurement to account for the variation in vessel diameter during the cardiac cycle.
- Quantity of blood across the SVC: To be measured using the VTI (velocity time integral) from pulsed Doppler echocardiography from a low subcostal view
Measured: One hour after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souvik Mitra, McMaster University
- Investigators
- Souvik Mitra, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528851
- Sponsor's protocol ID
- CO-PAP
- Acronym
- CO-PAP
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High Endotracheal Airway Pressures in Preterm Infants: A Randomized Cross-Over Trial
- ClinicalTrials.gov ID
- NCT02528851
- Acronym / sponsor ID
- CO-PAP / CO-PAP
- Conditions
- Preterm Infant
- Keywords
- CPAP, preterm, cardiac output
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 Aug 2015 (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 aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on conventional ventilation] at time of extubation. Participants will be randomized to "higher" CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We hypothesize that "higher" CPAP levels, when compared to "equivalent" CPAP levels, do not adversely impact the cardiorespiratory status when a patient is extubated from high EAP.
Detailed description
Extubation readiness of the enrolled infants will be determined solely by and at the discretion of the medical team. All enrolled infants will be checked to re-confirm eligibility prior to extubation. Those enrolled infants who are ventilated on EMV (endotracheal mechanical ventilation) with an airway pressure of 8-11 cm H2O at the time when they are deemed extubation-ready by the team will be eligible for randomization. Once eligibility for randomization is assessed, the study coordinator will notify the research team who will immediately perform a bedside functional echocardiography to assess cardiac output and PDA (patent ductus arteriosus) status. In addition, the lung compliance (as measured by the ventilator) will be recorded. If a PDA exists and is found to be hemodynamically significant, then the infant meets one of the exclusion criteria and will be ineligible for randomization.
Once eligibility is confirmed, infants will be randomized using sequentially numbered sealed opaque envelopes. The sequence of the randomization will be pre-determined using a computer generated algorithm, and sealed envelopes will be created by study coordinator. Once randomized, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation.
After ensuring that the infants are stable for one hour (based on pre-defined clinical instability criteria) cardiac output will be measured using bedside functional echocardiography by members of the research team blinded to the allocation. To ensure blinding the research coordinator will cover the relevant digital display of the ventilator/CPAP machine (with opaque craft paper and tape) immediately prior to the echocardiography. Other aforementioned outcomes will be recorded by the blinded investigator using standardized data collection forms. Once all outcome data are collected, the infants will cross-over to the opposite arm of the trial and a similar assessment protocol will be followed after one hour. The study protocol will be considered completed when the second set of measurements is obtained and further respiratory management will be guided by the medical team.
SAFETY ASSURANCE At any point during the study, emergence of any one of the clinical instability criteria will prompt the nursing staff to notify the medical team who would immediately assess the infant. If the infant shows signs of clinical instability the medical team will evaluate the infants' clinical condition as per a pre-defined checklist. When all the troubleshooting points mentioned in the checklist are addressed by the medical team and the infant is deemed clinically unstable, the infant would be immediately removed from the study protocol and parents of the subject will be notified. To ensure that no other factor affects the hemodynamic status of the infants during the study, the total fluid intake would remain the same and no caffeine citrate would be administered during the period of pre and post extubation assessment of cardiac output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher CPAP | Experimental | Procedure: Extubation from endotracheal mechanical ventilation to CPAPInfants extubated to CPAP level 2cm H2O higher than extubation EAP |
| Equivalent CPAP | Active comparator | Procedure: Extubation from endotracheal mechanical ventilation to CPAPInfants extubated to CPAP equivalent to extubation EAP |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All preterm infants less than 37 weeks of gestation who are mechanically ventilated with Endotracheal Airway Pressure (EAP) ≥ 8 cm H2O at time of extubation as per the medical team.
- Note: The decision to extubate a subject, and EAP at time of extubation, will solely be that of the medical team, and is in no way dictated by the study protocol.
Key exclusion criteria (10 listed)
- Infants on EMV with EAP> 11 cmH2O at the time of extubation
- Congenital or acquired abnormality of upper airway
- Major gastrointestinal disorder or complication
- Suspected/proven chromosomal/genetic abnormality
- Suspected/confirmed sepsis being treated at time of extubation
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 |
|---|---|---|
| Extubation from endotracheal mechanical ventilation to CPAPFollowing randomization, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation. | Procedure or surgery | Equivalent CPAP, Higher CPAP |
Primary outcome
Left ventricular output
Time frame: One hour after each intervention
We will use the formula LVO = [LV Outflow Tract (LVOT) area x Quantity of blood across LVOT x heart rate]/body weight (ml/kg/min). The details of measurement of each component of the equation are as follows: * LVOT area = π (LV outflow tract diameter/2)2. LV outflow tract diameter will be measured in the parasternal long axis in late systole immediately distal to the valve orifice using the leading edge technique. * Quantity of blood across the LVOT: To be measured using the VTI (velocity time integral) from pulsed Doppler echocardiography from the modified apical view (5-chamber view)
7 secondary outcomes
Heart rate
Time frame: One hour after each intervention
Blood pressure
Time frame: One hour after each intervention
abdominal wall girth
Time frame: One hour after each intervention
Silverman-Andersen respiratory score
Time frame: One hour after each intervention
Lung compliance
Time frame: Pre-extubation measurement in all recruited infants
Inferior vena caval diameter
Time frame: One hour after each intervention
Superior vena caval flow
Time frame: One hour after each intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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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.
Amit Mukerji, MD contact
Souvik Mitra, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Extubation from endotracheal mechanical ventilation to CPAP in people with Preterm Infant, run by McMaster University.
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 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: status not confirmed, as of the sponsor's last update on 19 Aug 2015. 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?
Contact Souvik Mitra, MD (19059621091, mitras@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular output (time frame: One hour after each intervention). 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 19 Aug 2015.