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

NCT ID: NCT05912855

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-10-31

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.

Conditions

Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

BPS（Behavioral Pain Scale）and physiological index monitoring guided analgesia group

No interventions assigned to this group

Analgesia group guided by qNOX

qNOX

Intervention Type: DEVICE

Non

Interventions

qNOX

Non

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guolin Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiaohong Tang, MD

Role: CONTACT

tangxiaohong_txh@qq.com

+8618522725286

Guolin Wang, MD

Role: CONTACT

wang_guolin@hotmail.com

86-022-60362606

Other Identifiers

GWang009

Identifier Type: -

Identifier Source: org_study_id