Intensive Care Unit ICUNCT06692400
The Effects of Endotracheal Suctioning on Pain and Serum Markers
A study testing endotracheal tube suctioning in people with Intensive Care Unit ICU and Intubation, run by Loma Linda University at 1 site in United States.
Trial summary
The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit ICU, Intubation, Critical Illness
- What is being tested?
- endotracheal tube suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2025to Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged 18 years and older)
- Current diagnosis of flu, pneumonia, COVID, or sepsis
- Intubated and receiving mechanical ventilation.
- Have arterial lines placed
- Require endotracheal suctioning as part of their care
Who cannot join
- Patients receiving neuromuscular blocking agents
- Contraindications for blood draws (hemoglobin levels below 8.0 g/dL; Jehovah's Witness)
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
Loma Linda University Medical Center Troesh Medical Campus
Loma Linda, California, 92354
Loma Linda University Health, 877-558-6248, irb@llu.edu
Briana Carr, PhD(c), MEd, BA, BSN, RN
About this study
Official title: The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial
The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress.
The main questions this study aims to answer are:
Read more
Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress.
Participants will:
Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning.
Provide demographic information (like age, gender, and diagnosis) from medical records.
This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.
- Conditions
- Intensive Care Unit ICU, Intubation, Critical Illness, Mechanical Ventilation, Pain Measurement, Pain, Procedural
- Being tested
- endotracheal tube suctioning
- Medical subject headings
- Critical Illness, Pain, Procedural, Hypoxia, Sepsis, Influenza, Human, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tube suctioningProcedure or surgery
Endotracheal tube suctioning occurs as part of normal care for intubated patients. This procedure will serve as the painful procedure to assess CPOT and biomarkers of hypoxia and oxidative stress.
| Study group | Role | What they receive |
|---|---|---|
| Participants who undergo endotracheal tube (ETT) suctioning. | Experimental | Participants will receive ETT suctioning as part of routine care. Receives: Procedure: endotracheal tube suctioning |
| Participants who do not undergo ETT suctioning during the observation period. | No intervention | Participants will not receive ETT suctioning during the observation periood. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of ETT suctioning on subject pain level
The Critical-Care Pain Observation Tool (CPOT) is a composite measurement used to assess pain in non-verbal ICU patients by evaluating four behavioral indicators: facial expression, body movements, muscle tension, and ventilator compliance (for intubated patients) or vocalization (for non-intubated patients). Each indicator is scored from 0 (no pain behavior) to 2 (intense pain behavior), resulting in a total score from 0 to 8. Higher scores indicate higher pain levels, guiding clinicians in pain management. For example, a score of 0 indicates no pain, while a score of 2 in any category suggests more severe pain, prompting possible adjustments in analgesic care.
Measured: Change between baseline CPOT score and 30-minutes post suctioning CPOT score.
Impact of ETT suctioning on subject serum markers of hypoxia and oxidative stress (Hypoxanthine).
Serum markers will be obtained via arterial line blood draw 5 minutes pre-ETT suctioning and again post-ETT suctioning. Normal blood concentrations of hypoxanthine in healthy adult individuals are less than 5 µmol. Levels greater than 5 µmol indicate hypoxia and oxidative stress.
Measured: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start30 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit ICUStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Johnston Taylor, PhD, FAAN, Principal investigator, Loma Linda University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692400
- Sponsor's protocol ID
- 5240556
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the completion of this experiment, specific IPD will be shared in de-identified form to support transparency, replication, and further research: Demographic data (age, gender, diagnosis) relevant to understanding participant characteristics. Pain assessment scores (Critical-Care Pain Observation Tool \[CPOT\] scores) collected at baseline, 5 minutes, and 30 minutes post-suctioning. Biochemical marker levels for hypoxanthine, xanthine, and uric acid, measured at the same time points. The IPD will be accessible to qualified researchers upon reasonable request and after ethical and institutional review, following institutional and regulatory guidelines for data sharing. Data will be shared primarily for the purposes of publication in peer-reviewed journals and to facilitate future studies that may enhance supportive care protocols for ICU patients. The data will be available through an encrypted institutional repository to ensure participant confidentiality and data security.
Publications
Angeles DM, Boskovic DS, Tan JC, Shih W, Hoch E, Forde D, Phillips RM, Hopper A, Deming DD, Goldstein M, Truong G, Febre A, Pegis P, Lavery A, Kadri M, Banerji A, Mousselli I, Farha V, Fayard E. Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial. J Perinatol. 2020 Jun;40(6):888-895. doi: 10.1038/s41372-020-0634-0. Epub 2020 Feb 26.
PubMed 32103160
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial
- ClinicalTrials.gov ID
- NCT06692400
- Acronym / sponsor ID
- 5240556
- Conditions
- Intensive Care Unit ICU, Intubation, Critical Illness, Mechanical Ventilation, Pain Measurement, Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 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.
The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress.
The main questions this study aims to answer are:
Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress.
Participants will:
Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning.
Provide demographic information (like age, gender, and diagnosis) from medical records.
This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who undergo endotracheal tube (ETT) suctioning. | Experimental | Procedure: endotracheal tube suctioningParticipants will receive ETT suctioning as part of routine care. |
| Participants who do not undergo ETT suctioning during the observation period. | No intervention | –Participants will not receive ETT suctioning during the observation periood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (aged 18 years and older)
- Current diagnosis of flu, pneumonia, COVID, or sepsis
- Intubated and receiving mechanical ventilation.
- Have arterial lines placed
- Require endotracheal suctioning as part of their care
Key exclusion criteria (2 listed)
- Patients receiving neuromuscular blocking agents
- Contraindications for blood draws (hemoglobin levels below 8.0 g/dL; Jehovah's Witness)
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 |
|---|---|---|
| endotracheal tube suctioningEndotracheal tube suctioning occurs as part of normal care for intubated patients. This procedure will serve as the painful procedure to assess CPOT and biomarkers of hypoxia and oxidative stress. | Procedure or surgery | Participants who undergo endotracheal tube (ETT) suctioning. |
Primary outcome
Impact of ETT suctioning on subject pain level
Time frame: Change between baseline CPOT score and 30-minutes post suctioning CPOT score.
The Critical-Care Pain Observation Tool (CPOT) is a composite measurement used to assess pain in non-verbal ICU patients by evaluating four behavioral indicators: facial expression, body movements, muscle tension, and ventilator compliance (for intubated patients) or vocalization (for non-intubated patients). Each indicator is scored from 0 (no pain behavior) to 2 (intense pain behavior), resulting in a total score from 0 to 8. Higher scores indicate higher pain levels, guiding clinicians in pain management. For example, a score of 0 indicates no pain, while a score of 2 in any category suggests more severe pain, prompting possible adjustments in analgesic care.
Impact of ETT suctioning on subject serum markers of hypoxia and oxidative stress (Hypoxanthine).
Time frame: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw
Serum markers will be obtained via arterial line blood draw 5 minutes pre-ETT suctioning and again post-ETT suctioning. Normal blood concentrations of hypoxanthine in healthy adult individuals are less than 5 µmol. Levels greater than 5 µmol indicate hypoxia and oxidative stress.
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 10 Jul 2026.
- Background: PubMed 32103160Angeles DM, Boskovic DS, Tan JC, Shih W, Hoch E, Forde D, Phillips RM, Hopper A, Deming DD, Goldstein M, Truong G, Febre A, Pegis P, Lavery A, Kadri M, Banerji A, Mousselli I, Farha V, Fayard E. Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial. J Perinatol. 2020 Jun;40(6):888-895. doi: 10.1038/s41372-020-0634-0. Epub 2020 Feb 26.
- Individual participant dataSharing planned: Yes. Following the completion of this experiment, specific IPD will be shared in de-identified form to support transparency, replication, and further research: Demographic data (age, gender, diagnosis) relevant to understanding participant characteristics. Pain assessment scores (Critical-Care Pain Observation Tool [CPOT] scores) collected at baseline, 5 minutes, and 30 minutes post-suctioning. Biochemical marker levels for hypoxanthine, xanthine, and uric acid, measured at the same time points. The IPD will be accessible to qualified researchers upon reasonable request and after ethical and institutional review, following institutional and regulatory guidelines for data sharing. Data will be shared primarily for the purposes of publication in peer-reviewed journals and to facilitate future studies that may enhance supportive care protocols for ICU patients. The data will be available through an encrypted institutional repository to ensure participant confidentiality and data security.
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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.
Elizabeth Johnston Taylor, PhD, FAAN principal investigator
Loma Linda University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal tube suctioning in people with Intensive Care Unit ICU and Intubation, run by Loma Linda 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 5 inclusion and 2 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 10 Jul 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 Briana Carr, PhD(c), BSN, RN (909-558-4000, bmcarr@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of ETT suctioning on subject pain level (time frame: Change between baseline CPOT score and 30-minutes post suctioning CPOT score.). The study lists 2 primary outcomes in all. 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 NCT06692400, which also lists 1 linked publication.
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 10 Jul 2026.