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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05912855
• Other study ID #: GWang009
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Tianjin Medical University General Hospital
• Contact: Xiaohong Tang, MD
• Phone: +8618522725286
• Email: tangxiaohong_txh[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• qNOX
Non

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of qNOX with BPS=5	Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.	During procedure