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

Sponsor
Tianjin Medical University General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912855
Collaborator
(none)
110
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: qNOX

Study Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
BPS(Behavioral Pain Scale)and physiological index monitoring guided analgesia group

Analgesia group guided by qNOX

Device: qNOX
Non

Outcome Measures

Primary Outcome Measures

  1. Value of qNOX with BPS≥5 [During procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tianjin Medical University General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guolin Wang, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT05912855
Other Study ID Numbers:
  • GWang009
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 27, 2023