Skip to main content
Clinical Trials/NCT06692400
NCT06692400
Recruiting
Not Applicable

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

Loma Linda University1 site in 1 country110 target enrollmentStarted: January 30, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
110
Locations
1
Primary Endpoint
Impact of ETT suctioning on subject pain level

Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Masking Description

The lab technician who results the labs will be blinded.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials