Clinical trial NCT06692400: The Effects of Endotracheal Suctioning on Pain and Serum Markers
Official title: The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Impact of ETT suctioning on subject pain level
timeFrame: Change between baseline CPOT score and 30-minutes post suctioning CPOT score.
measure: Impact of ETT suctioning on subject serum markers of hypoxia and oxidative stress (Hypoxanthine).
timeFrame: Change between baseline serum marker blood draw and 30-minutes post suctioning serum marker blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center Troesh Medical Campus
state: California
Study officials:
affiliation: Loma Linda University School of Nursing
name: Elizabeth Johnston Taylor, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.