To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients

Purpose: To explore the effect of analgesic management under the guidance of qNOX monitoring on the comfort level and prognosis of patients with mechanical ventilation in ICU.

Method:After admission to ICU, the patients were randomly divided into the analgesia group guided by BPS（Behavioral Pain Scale） and physiological indicators monitoring and qNOX-guided analgesia group (qNOX group). Sedation and analgesia program after admission to ICU (continuous injection pump) : propofol 1.5-4.5mg/kg.h, remifentanil 5-8ug/kg.h, maintain sedation goals RASS（Richmond Agitation-Sedation Scale）-3 to -4 scores, BPS（Behavioral Pain Scale）3 to 4 scores. The researchers worked with the bedside nurse to plan different care procedures, including :1) central venous catheter or arterial catheter puncture; 2) The patient is turned over completely so that the back can be washed and the sheets changed; 3) Endotracheal sputum aspiration (patients with intubation or in tracheotomy state ); 4) Dressing the wound.

Primary outcome:Value of qNOX at BPS（Behavioral Pain Scale）≥5 (qNOX sensitivity, specificity, positive predictive value and negative predictive value) Secondary outcome:To investigate the patient baseline variables that may affect qNOX; Variables that may influence qNOX in relation to critical illness.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Device: qNOX

Detailed Description

To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients. For critically ill patients, pain is a common and highly impactful experience. Acute pain not only has psychological effects but also correlates with poor prognosis, including prolonged mechanical ventilation, hemodynamic instability, increased endocrine pressure, and chronic pain. However, excessive use of analgesics can also cause harm such as immune dysfunction, low blood pressure, respiratory depression, chest wall stiffness, gastrointestinal motility disorders and opioid dependence.In awake and healthy individuals, acute pain typically arises from nociceptive stimuli. However, pain perception can occur unconsciously and still have detrimental effects. Therefore, meticulous monitoring and management of analgesic therapy to achieve an optimal balance between injury burden and medication dosage is crucial in critical care settings. Consequently, effective pain assessment methods are recommended to guide the administration of analgesics during intensive care treatment.

Inclusion criteria: Patients aged 18 years or older who are undergoing abdominal, orthopedic, ENT, urological, neurosurgical or cardiothoracic surgery and require ICU treatment with mechanical ventilation while having an RASS-3 or -4 score; patients unable to self-assess pain intensity using NRS but have signed informed consent forms.

Exclusion criteria: Patients under the age of 18; pregnant women; patients who cannot communicate due to cerebrovascular accidents; those who have decided to discontinue life support.

Primary outcome:Value of qNOX at BPS≥5 (qNOX sensitivity, specificity, positive predictive value and negative predictive value) Secondary outcome:To investigate the patient baseline variables that may affect qNOX; Variables that may influence qNOX in relation to critical illness.

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Xiaohong Tang, MD; Phone Number: +8618522725286; Email: tangxiaohong_txh@qq.com
• Study Contact Backup: Name: Guolin Wang, MD; Phone Number: 86-022-60362606; Email: wang_guolin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ICU patients receiving mechanical ventilation.

Description

Inclusion Criteria:

1. Patients aged 18 years or older who are undergoing abdominal, orthopedic, ENT（ear-nose-throat）, urological, neurosurgical or cardiothoracic surgery and require ICU treatment with mechanical ventilation while having an RASS（Richmond Agitation-Sedation Scale）-3 or -4 score;
2. Patients unable to self-assess pain intensity using NRS（Numerical Pain Rating Scale）;
3. Patients who have provided informed consent.

Exclusion Criteria:

1. < 18 years of age;
2. Pregnant individuals;
3. Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
4. A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Analgesia group guided by qNOX	Device: qNOX; Non
BPS（Behavioral Pain Scale）and physiological index monitoring guided analgesia group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of qNOX with BPS≥5	Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.	During procedure

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GWang009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No