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

Not yet recruiting

• Conditions: Pain
• Interventions: Device: qNOX

• Registration Number: NCT05912855
• Lead Sponsor: Tianjin Medical University General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Analgesia group guided by qNOX	qNOX	-

Primary Outcome Measures

Name	Time	Method
Value of qNOX with BPS≥5	During procedure	Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.