Mechanically Ventilated PatientsNCT04134481
Effect Of Clustered Nursing Interventions On Physiological Response In Critically Ill Patients
An observational study of Mechanically Ventilated Patients, run by Alexandria University.
Trial summary
To determine physiological responses related to clustered nursing interventions among critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to 1 Apr 2017
- How long will I take part?
- 2 Weeks
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 adult mechanically ventilated patients admitted to intensive care units of Alexandria Main University Hospital (unit I, unit III), General ICU of Damanhur Medical National Institute consists
Who may be able to join
- adult patients of both sex, aged 18 years and over
- mechanically ventilated for ≥ 48 hours.
Who cannot join
- lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS)
- pregnancy.
About this study
Official title: Physiological Responses Related to Clustered Nursing Interventions Among Mechanically Ventilated Patients
To determine physiological responses related to clustered nursing interventions among critically ill patients.
Read the detailed description
Clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.The study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of Alexandria Main University Hospital and Damanhour Medical National Institute. The most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. Physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.
- Conditions
- Mechanically Ventilated Patients
- Keywords
- clustered nursing interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low intervention group | from 0-7 clustered nursing intervention | |
| high intervention group | from 8-15 clustered nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in end tidal CO2 in mmHg (EtCO2) change in oxygen saturation (SO2)
measured 5 min before procedure (baseline), 5 min after start, 10 min after, immediately at end procedure, 15 min after end procedure for two weeks
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start15 Sep 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Hassan Dahroug, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134481
- Sponsor's protocol ID
- amr dahroug
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses Related to Clustered Nursing Interventions Among Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04134481
- Acronym / sponsor ID
- amr dahroug
- Conditions
- Mechanically Ventilated Patients
- Keywords
- clustered nursing interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 22 Oct 2019 (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.
To determine physiological responses related to clustered nursing interventions among critically ill patients.
Detailed description
Clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.The study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of Alexandria Main University Hospital and Damanhour Medical National Institute. The most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. Physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low intervention group | – | –from 0-7 clustered nursing intervention |
| high intervention group | – | –from 8-15 clustered nursing intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 adult mechanically ventilated patients admitted to intensive care units of Alexandria Main University Hospital (unit I, unit III), General ICU of Damanhur Medical National Institute consists
Key inclusion criteria (2 listed)
- adult patients of both sex, aged 18 years and over
- mechanically ventilated for ≥ 48 hours.
Key exclusion criteria (2 listed)
- lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS)
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in end tidal CO2 in mmHg (EtCO2) change in oxygen saturation (SO2)
Time frame: up to 14 days
measured 5 min before procedure (baseline), 5 min after start, 10 min after, immediately at end procedure, 15 min after end procedure for two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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?
An observational study of Mechanically Ventilated Patients, run by Alexandria 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in end tidal CO2 in mmHg (EtCO2) change in oxygen saturation (SO2) (time frame: up to 14 days). 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 22 Oct 2019.