MoralityRCCN TrainingNCT05941923
Respiratory Critical Care Nurse Training Program
A study testing respiratory critical care support in people with Morality and Treatment Compliance, run by Baqiyatallah Medical Sciences University.
Trial summary
The goal of this clinical trial study is to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Morality, Treatment Compliance
- What is being tested?
- respiratory critical care support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Nov 2024
- Phase
- Interventional
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are at least 18 years old,
- Critically ill patients who need critical care,
- They have no history of heart disease, stroke, autoimmune disease, neuromuscular diseases, cancer, or cardio-respiratory arrest,
- They are willing to participate in the study.
Who cannot join
- Patients with pregnancy and breastfeeding women
- Patients at end-stage medical condition
- Patients with planned withdrawal of treatment
About this study
Official title: A Respiratory Critical Care Nurse Training Program for Countries Without Registered Respiratory Therapist: A Randomize Clinical Trial
The goal of this clinical trial study is to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). The main question it aims to answer is: What is the effect of the respiratory critical care nurse in improving outcomes for critically ill patients? Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care.
Read the detailed description
A randomized controlled clinical superiority trial with triple blinding and a two-arm parallel group design will be conducted at Baqiyatallah University of Medical Sciences in Tehran, Iran between November 22, 2023, and November 10, 2024. The aim of this study will to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care
- Conditions
- Morality, Treatment Compliance
- Being tested
- respiratory critical care support
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory critical care supportOther
Patients in the intervention group will be received respiratory critical care support
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The experimental group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital Receives: Other: respiratory critical care support |
| Control group | No intervention | No intervention group, who will receive only routine care without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
The primary outcome of this study will be to compare mortality rates between two study groups.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Treatment failures
The secondary outcome will be the proportion of treatment failures, which is defined by a composite endpoint consisting of the need for non-invasive ventilation (NIV), intubation, or death
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical superiority trial with two-arm parallel group design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941923
- Sponsor's protocol ID
- Respiratory Nurse
- Acronym
- RCCN Training
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Respiratory Critical Care Nurse Training Program for Countries Without Registered Respiratory Therapist: A Randomize Clinical Trial
- ClinicalTrials.gov ID
- NCT05941923
- Acronym / sponsor ID
- RCCN Training / Respiratory Nurse
- Conditions
- Morality, Treatment Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jul 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.
The goal of this clinical trial study is to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). The main question it aims to answer is: What is the effect of the respiratory critical care nurse in improving outcomes for critically ill patients? Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care.
Detailed description
A randomized controlled clinical superiority trial with triple blinding and a two-arm parallel group design will be conducted at Baqiyatallah University of Medical Sciences in Tehran, Iran between November 22, 2023, and November 10, 2024. The aim of this study will to evaluate the clinical effectiveness of respiratory critical care nurses (RCCN) in improving outcomes for critically ill patients who require admission to the intensive care units (ICUs). Participants will consist of critically ill patients who will be randomly allocated in a 1:1 ratio into two groups: the intervention group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital, and the control group, who will receive only routine care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical superiority trial with two-arm parallel group design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: respiratory critical care supportThe experimental group, who will receive specialized respiratory care from RCCN from the time they arrive in the emergency room until their discharge from the hospital |
| Control group | No intervention | –No intervention group, who will receive only routine care without any intervention. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- They are at least 18 years old,
- Critically ill patients who need critical care,
- They have no history of heart disease, stroke, autoimmune disease, neuromuscular diseases, cancer, or cardio-respiratory arrest,
- They are willing to participate in the study.
Key exclusion criteria (3 listed)
- Patients with pregnancy and breastfeeding women
- Patients at end-stage medical condition
- Patients with planned withdrawal of treatment
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 |
|---|---|---|
| respiratory critical care supportPatients in the intervention group will be received respiratory critical care support | Other | Intervention group |
Primary outcome
Mortality rate
Time frame: through study completion, an average of 3 months
The primary outcome of this study will be to compare mortality rates between two study groups.
1 secondary outcome
Treatment failures
Time frame: through study completion, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory critical care support in people with Morality and Treatment Compliance, run by Baqiyatallah Medical Sciences University.
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 4 inclusion and 3 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 12 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: through study completion, an average of 3 months). 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 12 Jul 2023.