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

June 24, 2023 updated by: Guolin Wang, Tianjin Medical University General Hospital

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

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Value of qNOX with BPS≥5
Time Frame: During procedure
Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University General Hospital

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

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July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

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June 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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