The Effects of Endotracheal Suctioning on Pain and Serum Markers

Not Applicable

Recruiting

• Conditions: Intensive Care Unit ICU; Intubation; Critical Illness; Mechanical Ventilation; Pain Measurement; Pain, Procedural; Oxidative Stress; Hypoxia; Biomarkers / Blood; Adult

• Registration Number: NCT06692400
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-14
• Study First Posted: 2024-11-18
• Study Start: 2025-01-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of ETT suctioning on subject pain level	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).	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center Troesh Medical Campus; 🇺🇸 Loma Linda, California, United States