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Recruiting NCT06692400

The Effects of Endotracheal Suctioning on Pain and Serum Markers

No phase Interventional Intensive Care Unit ICU Intubation Critical Illness Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endotracheal tube suctioning.
Who it may be relevant to
Registry conditions: Intensive Care Unit ICU, Intubation, Critical Illness, Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial

Overview

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.

Interventions

  • Procedure endotracheal tube suctioning
    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.

Primary outcome measures

  • Impact of ETT suctioning on subject pain level [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). [Time frame: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Patients receiving neuromuscular blocking agents
  • Contraindications for blood draws (hemoglobin levels below 8.0 g/dL; Jehovah's Witness)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Loma Linda University Medical Center Troesh Medical Campus — Loma Linda

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 PMID 32103160

Identifiers

NCT: NCT06692400 · 5240556

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗