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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Rakesh Sahni, MD contact

212-305-9743

rs62@cumc.columbia.edu

United States1 site, 1 recruiting
  • Columbia University Irving Medical Center

    New York, New York, 10032-3720

    Rakesh Sahni, MD, 2123059743, rs62@cumc.columbia.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT06443970
Study groupRoleWhat they receive
Exsalta Device suctioningExperimentalNot described
Receives: Device: Exsalta Suction Device
Coventional wall suctioningActive comparatorNot described
Receives: Device: Exsalta Suction Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in heart rate (HR)

    Measured as beats per minute

    Measured: Before suctioning (baseline) and up to 1-hour after suctioning

  2. Change in oxygen saturation (SpO2)

    Measured as percent (%) change

    Measured: Before suctioning (baseline) and up to 1-hour after suctioning

  3. Change in cerebral oxygenation (C-rSO2)

    Measured as percent (%) change

    Measured: Before suctioning (baseline) and up to 1-hour after suctioning

  4. 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)
  1. Incidence of bradycardia

    Count (episodes) of HR<80% for more than 10 sec

    Measured: Before suctioning (baseline) and up to 1-hour after suctioning

  2. 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.

  1. First posted5 Jun 2024
  2. Study start4 Sep 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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)
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

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.

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