The Effects of Endotracheal Suctioning on Pain and Serum Markers

NCT06692400 | Recruiting

• 1 other identifier: 5240556
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit ICU; Intubation; Critical Illness; Mechanical Ventilation; Pain Measurement; Pain, Procedural; Oxidative Stress; Hypoxia; Biomarkers / Blood; Adult; Uric Acid; Sepsis; COVID; Influenza; Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw

Study Arms (2)

Participants who undergo endotracheal tube (ETT) suctioning.

EXPERIMENTAL

Participants will receive ETT suctioning as part of routine care.

Procedure: endotracheal tube suctioning

Participants who do not undergo ETT suctioning during the observation period.

NO INTERVENTION

Participants will not receive ETT suctioning during the observation periood.

Interventions

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.

Participants who undergo endotracheal tube (ETT) suctioning.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center Troesh Medical Campus

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (1)

• 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 2020 Feb 26.

  PMID: 32103160 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Pain, Procedural; Hypoxia; Sepsis; Influenza, Human; Pneumonia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Respiratory; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases

Study Officials

• Elizabeth Johnston Taylor, PhD, FAAN

  Loma Linda University School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Briana Carr, PhD(c), BSN, RN

CONTACT

909-558-4000; bmcarr@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The lab technician who results the labs will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: January 30, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, 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.

Locations

US (1)