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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05912855
Enrollment
110
Registered
2023-06-22
Start date
2023-06-30
Completion date
2024-10-31
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DEVICEqNOX

Non

Sponsors

Tianjin Medical University General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Value of qNOX with BPS≥5During procedureSensitivity, specificity, positive predictive value and negative predictive value of qNOX.

Contacts

Primary ContactXiaohong Tang, MD
tangxiaohong_txh@qq.com+8618522725286
Backup ContactGuolin Wang, MD
wang_guolin@hotmail.com86-022-60362606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026