Respiratory FailureNCT06443970
Low and High Flow Suctioning in Intubated Infants
A study testing Exsalta Suction Device in people with Respiratory Failure, run by Columbia University at 1 site in United States.
Trial summary
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Exsalta Suction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm and term infants with birth weight more than 1000g receiving ETT suctioning
Who cannot join
- Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032-3720
Rakesh Sahni, MD, 2123059743, rs62@cumc.columbia.edu
About this study
Official title: Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.
Read the detailed description
Respiratory failure in neonates frequently requires mechanical ventilation through an endotracheal tube (ETT). The presence of an ETT inhibits the infant's intrinsic ability to clear endogenous lung secretions effectively with compromised glottic closure and impaired muccociliary function, and thus regular supportive suctioning of the ETT is essential. The benefits of patent airway are evident, but adverse effects may also result from suctioning which are especially deleterious in extremely preterm infants with immature pulmonary and systemic hemodynamic function. These adverse effects include transient hypoxemia and oxygen desaturation, vasovagal reactions, altered central and cerebral hemodynamics, atelectasis, pneumothorax, and mucosal damage. The cardiorespiratory instability during ETT suctioning is partially attributed to alveolar decruitment and loss of lung volume from disconnecting the ETT from the ventilator circuit and negative suction pressure. Maintenance of lung volume is essential to optimize gas exchange and prevent ventilator induced lung injury. The magnitude of lung volume loss is related to catheter size and applied suctioning pressure and flow, highlighting the complexity of interaction between suction technique, lung mechanics and disease state. In accordance with industry standard codes, a high flow rate is essential to ensure the rapid removal of fluid and secretions from the desired site and the standard conventional wall (SCW) suction outlets provide a minimum flow of approximately 85 liters per minute. Such high flows can lead to endotracheal suctioning-induced alveolar decruitment that may of significant clinical relevance. Recently, a low flow technology suction device EXSALTA (ED) for clearing ETT secretions in patients on ventilators has been approved by FDA. The device uses peristaltic action to move fluids from the patient to a collection canister at a fixed flow rate of 1.4 L/min and eliminates the uncontrolled flow of air from the patient's lungs. The user selects a desired pressure level that is independent of the flow rate, a feature unavailable with SCW wall suction equipment used at patient's bedside. This exceptional microprocessor-controlled tabletop suction device, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and hypoxia associated with standard suctioning techniques. This study will examine the hypothesis that there will be significantly lower variations in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (c-FOE) with ED compared to SCW suction system during open or closed ETT suctioning. To test this hypothesis, the physiological consequences of two ETT suctioning systems in preterm and term infants will be evaluated using the following aims:
AIM 1. To compare the variations in HR (bpm), SpO2 (%), C-rSO2 (%), C-FOE (%) between ED and SCW suctioning systems during routine standard care open and closed ETT suctioning.
AIM II. To compare the incidence (episodes) of cardiorespiratory disturbances, i.e. bradycardia (HR<80 bpm) and/or hemoglobin oxygen desaturation (SpO2) < 80% for more than 10s during suctioning with ED and SCW suctioning system during routine standard care open and closed ETT suctioning.
- Conditions
- Respiratory Failure
- Being tested
- Exsalta Suction Device
- Keywords
- cardiorespiratory disturbances, neonates, EXSALTA, Endotracheal Suctioning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exsalta Suction DeviceDevice
Low flow endotracheal suction device
| Study group | Role | What they receive |
|---|---|---|
| Exsalta Device suctioning | Experimental | Not described Receives: Device: Exsalta Suction Device |
| Coventional wall suctioning | Active comparator | Not described Receives: Device: Exsalta Suction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate (HR)
Measured as beats per minute
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Change in oxygen saturation (SpO2)
Measured as percent (%) change
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Change in cerebral oxygenation (C-rSO2)
Measured as percent (%) change
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Change in cerebral fractional oxygen extraction (c-FOE)
Measured as difference in SpO2 and C-rSO2 (%)
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Secondary outcomes (2)
Incidence of bradycardia
Count (episodes) of HR<80% for more than 10 sec
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Incidence of hemoglobin oxygen desaturation
Count (episodes) of SpO2<80% for more than 10 sec
Measured: Before suctioning (baseline) and up to 1-hour after suctioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start4 Sep 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- In each group of study infants (open and closed ETT suctioning), the enrolled subjects will experience ETT suctioning with both methods, i.e. with ED and SCW suctioning systems. Each study infant will undergo two sequential suctioning procedures each day during the two-day study period. On day-1, the infant will be randomly assigned the ED or SCW suctioning device during the first maneuver and the devices will be alternated during the second maneuver. The suctioning device order will be reversed on study day-2 as shown in the study protocol below. In all each infant will have four suctioning maneuvers over two days, two each with ED and SCW suctioning devices.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Sahni, Columbia University
- Investigators
- Rakesh Sahni, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443970
- Sponsor's protocol ID
- AAAU9006
- Status last verified
- Apr 2026
- First submitted
- 13 May 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Consequences of Low and High Flow Endotracheal Suctioning Devices in Intubated Preterm and Term Infants
- ClinicalTrials.gov ID
- NCT06443970
- Acronym / sponsor ID
- AAAU9006
- Conditions
- Respiratory Failure
- Keywords
- cardiorespiratory disturbances, neonates, EXSALTA, Endotracheal Suctioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Jun 2024 (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.
Preterm and term intubuted infants in the NICU will undergo two sequential suctioning procedures: a new, FDA-approved suction device called EXSALTA (ED) and the standard conventional wall (SCW). The physiological consequences, i.e. changes in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (C-FOE) between ED and SCW ETT tracheal suctioning system in both open and closed catheter system settings will be evaluated using a randomized cross over design in preterm and term infants receiving mechanical ventilation via an ETT. This study will evaluate the hypothesis that there will be significantly lower variations in HR, SpO2, C-rSO2, and C-FOE during ETT suctioning with ED compared to SCW suctioning systems under both open and close ETT suction settings.
Detailed description
Respiratory failure in neonates frequently requires mechanical ventilation through an endotracheal tube (ETT). The presence of an ETT inhibits the infant's intrinsic ability to clear endogenous lung secretions effectively with compromised glottic closure and impaired muccociliary function, and thus regular supportive suctioning of the ETT is essential. The benefits of patent airway are evident, but adverse effects may also result from suctioning which are especially deleterious in extremely preterm infants with immature pulmonary and systemic hemodynamic function. These adverse effects include transient hypoxemia and oxygen desaturation, vasovagal reactions, altered central and cerebral hemodynamics, atelectasis, pneumothorax, and mucosal damage. The cardiorespiratory instability during ETT suctioning is partially attributed to alveolar decruitment and loss of lung volume from disconnecting the ETT from the ventilator circuit and negative suction pressure. Maintenance of lung volume is essential to optimize gas exchange and prevent ventilator induced lung injury. The magnitude of lung volume loss is related to catheter size and applied suctioning pressure and flow, highlighting the complexity of interaction between suction technique, lung mechanics and disease state. In accordance with industry standard codes, a high flow rate is essential to ensure the rapid removal of fluid and secretions from the desired site and the standard conventional wall (SCW) suction outlets provide a minimum flow of approximately 85 liters per minute. Such high flows can lead to endotracheal suctioning-induced alveolar decruitment that may of significant clinical relevance. Recently, a low flow technology suction device EXSALTA (ED) for clearing ETT secretions in patients on ventilators has been approved by FDA. The device uses peristaltic action to move fluids from the patient to a collection canister at a fixed flow rate of 1.4 L/min and eliminates the uncontrolled flow of air from the patient's lungs. The user selects a desired pressure level that is independent of the flow rate, a feature unavailable with SCW wall suction equipment used at patient's bedside. This exceptional microprocessor-controlled tabletop suction device, available at any suction setting, reduces risk of negative pressures in the lungs to help prevent alveolar collapse and hypoxia associated with standard suctioning techniques. This study will examine the hypothesis that there will be significantly lower variations in heart rate (HR), oxygen saturation (SpO2), cerebral oxygenation (C-rSO2), and cerebral fractional oxygen extraction (c-FOE) with ED compared to SCW suction system during open or closed ETT suctioning. To test this hypothesis, the physiological consequences of two ETT suctioning systems in preterm and term infants will be evaluated using the following aims:
AIM 1. To compare the variations in HR (bpm), SpO2 (%), C-rSO2 (%), C-FOE (%) between ED and SCW suctioning systems during routine standard care open and closed ETT suctioning.
AIM II. To compare the incidence (episodes) of cardiorespiratory disturbances, i.e. bradycardia (HR<80 bpm) and/or hemoglobin oxygen desaturation (SpO2) < 80% for more than 10s during suctioning with ED and SCW suctioning system during routine standard care open and closed ETT suctioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In each group of study infants (open and closed ETT suctioning), the enrolled subjects will experience ETT suctioning with both methods, i.e. with ED and SCW suctioning systems. Each study infant will undergo two sequential suctioning procedures each day during the two-day study period. On day-1, the infant will be randomly assigned the ED or SCW suctioning device during the first maneuver and the devices will be alternated during the second maneuver. The suctioning device order will be reversed on study day-2 as shown in the study protocol below. In all each infant will have four suctioning maneuvers over two days, two each with ED and SCW suctioning devices.
| Arm | Type | Receives |
|---|---|---|
| Exsalta Device suctioning | Experimental | Device: Exsalta Suction Device |
| Coventional wall suctioning | Active comparator | Device: Exsalta Suction Device |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm and term infants with birth weight more than 1000g receiving ETT suctioning
Key exclusion criteria (1 listed)
- Infants with cyanotic congenital heart disease and cardiac rhythm disorders (arrythmias) will be excluded from the study.
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 |
|---|---|---|
| Exsalta Suction DeviceLow flow endotracheal suction device | Device | Coventional wall suctioning, Exsalta Device suctioning |
Primary outcome
Change in heart rate (HR)
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Measured as beats per minute
Change in oxygen saturation (SpO2)
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Measured as percent (%) change
Change in cerebral oxygenation (C-rSO2)
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Measured as percent (%) change
Change in cerebral fractional oxygen extraction (c-FOE)
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Measured as difference in SpO2 and C-rSO2 (%)
2 secondary outcomes
Incidence of bradycardia
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Incidence of hemoglobin oxygen desaturation
Time frame: Before suctioning (baseline) and up to 1-hour after suctioning
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
Rakesh Sahni, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exsalta Suction Device in people with Respiratory Failure, run by Columbia University 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rakesh Sahni, MD (212-305-9743, rs62@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate (HR) (time frame: Before suctioning (baseline) and up to 1-hour after suctioning). The study lists 4 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 13 Apr 2026.