NCT05941923

Brief 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). 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

June 22, 2023

Last Update Submit

July 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    The primary outcome of this study will be to compare mortality rates between two study groups.

    through study completion, an average of 3 months

Secondary Outcomes (1)

  • Treatment failures

    through study completion, an average of 3 months

Other Outcomes (10)

  • Rate of endotracheal intubation

    through study completion, an average of 3 months

  • Rate of non-invasive ventilation (NIV)

    through study completion, an average of 3 months

  • Rate of ventilator-associated pneumonia (VAP)

    through study completion, an average of 3 months

  • +7 more other outcomes

Study Arms (2)

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

Other: respiratory critical care support

Control group

NO INTERVENTION

No intervention group, who will receive only routine care without any intervention.

Interventions

Patients in the intervention group will be received respiratory critical care support

Intervention group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with pregnancy and breastfeeding women
  • Patients at end-stage medical condition
  • Patients with planned withdrawal of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Triple blinding : Patients, respiratory critical care nurses, and data analyzers will be blinded to the allocation
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A randomized controlled clinical superiority trial with two-arm parallel group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 12, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07