PainNCT05912855
To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients
An observational study of Pain, run by Tianjin Medical University General Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- qNOX
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients receiving mechanical ventilation.
Who may be able to join
- 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;
- Patients unable to self-assess pain intensity using NRS（Numerical Pain Rating Scale）;
- Patients who have provided informed consent.
Who cannot join
- < 18 years of age;
- Pregnant individuals;
- Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
- A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- qNOX
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qNOXDevice
Non
| Study group | Role | What they receive |
|---|---|---|
| BPS（Behavioral Pain Scale）and physiological index monitoring guided analgesia group | Not described | |
| Analgesia group guided by qNOX | Not described Receives: Device: qNOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of qNOX with BPS≥5
Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912855
- Sponsor's protocol ID
- GWang009
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT05912855
- Acronym / sponsor ID
- GWang009
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPS（Behavioral Pain Scale）and physiological index monitoring guided analgesia group | – | – |
| Analgesia group guided by qNOX | – | Device: qNOX |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients receiving mechanical ventilation.
Key inclusion criteria (3 listed)
- 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;
- Patients unable to self-assess pain intensity using NRS（Numerical Pain Rating Scale）;
- Patients who have provided informed consent.
Key exclusion criteria (4 listed)
- < 18 years of age;
- Pregnant individuals;
- Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
- A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qNOXNon | Device | Analgesia group guided by qNOX |
Primary outcome
Value of qNOX with BPS≥5
Time frame: During procedure
Sensitivity, specificity, positive predictive value and negative predictive value of qNOX.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohong Tang, MD (+8618522725286, tangxiaohong_txh@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of qNOX with BPS≥5 (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.