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NCT Number: NCT06692400

The Effects of Endotracheal Suctioning on Pain and Serum Markers

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.

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Key information

Conditions

Intensive Care Unit ICU Adult Biomarkers / Blood COVID Critical Illness Disease Attributes Hypoxia Infections Inflammation Influenza Influenza, Human Intubation Lung Diseases Mechanical Ventilation Neurologic Manifestations Orthomyxoviridae Infections Oxidative Stress Pain Pain Measurement Pain, Procedural Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sepsis Signs and Symptoms Signs and Symptoms, Respiratory Systemic Inflammatory Response Syndrome Uric Acid Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center Troesh Medical Campus

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Briana Carr, PhD(c), MEd, BA, BSN, RN

PRINCIPAL_INVESTIGATOR

Loma Linda University Health

CONTACT

[email protected]

877-558-6248

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

endotracheal tube suctioning

Procedure

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 outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Briana Carr, PhD(c), BSN, RN

CONTACT

[email protected]

909-558-4000

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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