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Clinical Trials/NCT05912855
NCT05912855
Not yet recruiting
Not Applicable

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

Tianjin Medical University General Hospital0 sites110 target enrollmentJune 2023
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Tianjin Medical University General Hospital
Enrollment
110
Primary Endpoint
Value of qNOX with BPS≥5
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2023
End Date
October 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guolin Wang

Professor

Tianjin Medical University General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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;
  • Patients unable to self-assess pain intensity using NRS(Numerical Pain Rating Scale);
  • Patients who have provided informed consent.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Value of qNOX with BPS≥5

Time Frame: During procedure

Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.

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