An interventional study of endotracheal tube suctioning in Intensive Care Unit ICU, Intubation and Critical Illness, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Loma Linda University · Not applicable, Interventional, and Supportive care
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 110 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Compared within Pain, Procedural, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ETT suctioning as part of routine care.
Procedure: endotracheal tube suctioning
Participants will not receive ETT suctioning during the observation periood.
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.
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.
Time frame: 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.
Time frame: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Beginning 6 months after publication with no end date
Access criteria: Who: Researchers with a verified institutional affiliation and approval from their IRB or ethics committee, as applicable. Requests from researchers affiliated with reputable institutions will be reviewed by the primary investigator and the Loma Linda University Health IRB. What: De-identified IPD, including Demographic data (age, gender, diagnosis); CPOT pain scores recorded at baseline, 5 minutes, and 30 minutes post-suctioning; Biochemical marker levels (hypoxanthine, xanthine, uric acid) measured at the same time points. Relevant study protocols and descriptions of data collection and processing procedures. How: Interested researchers must submit a data access request, including a brief research proposal, institutional affiliation, and IRB or ethics approval. Approved researchers will sign a Data Use Agreement (DUA) outlining the terms of use, data confidentiality requirements, and publication guidelines. Access will be provided through a secure, encrypted institutional repository.
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