Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure

March 23, 2025 updated by: Muş Alparslan University

Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure: A Randomized Controlled Trial

This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypoxic respiratory failure is responsible for 1.9 million patient admissions per year in the United States alone, and the hospital mortality rate is as high as 20%. This rate is also increasing in Turkey. The most common causes include pneumonia, cardiogenic pulmonary edema, ARDS, and chronic obstructive pulmonary disease (COPD). Fast hugs is important in affecting the prognosis of patients with hypoxic respiratory failure in special clinics such as the Chest Diseases Intensive Care Unit. Therefore, new studies are needed. This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25040
        • Recruiting
        • Ataturk University Research Hospital
        • Contact:
        • Principal Investigator:
          • Gamze KOÇ, Specialist
        • Sub-Investigator:
          • Burak YAVUZ, Specialist
        • Sub-Investigator:
          • Bahar ÇİFTÇİ, Associate Professor
        • Sub-Investigator:
          • Hanım Duru YÜCE BAŞARAN, Specialist
        • Sub-Investigator:
          • Dilara KOÇYİĞİT, Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being over 18 years old
  • Being in the Chest Intensive Care Unit
  • Having Hypoxic Respiratory Failure

Exclusion Criteria:

  • Death during hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist).
Other: FAST HUGS WITH ICU approach
FAST HUGS WITH ICU; It is an abbreviation of "Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist". With this approach, patients will be followed up.
No Intervention: Control Group
The standard procedure will be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: 1 month
The difference between the duration of participants' admission to the intensive care unit and the time they are discharged from the intensive care unit will be examined.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muş Alparslan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Güzel Nur YILDIZ, Dr, Muş Alparslan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MuşAlparslan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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