NCT04134481

Brief Summary

To determine physiological responses related to clustered nursing interventions among critically ill patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Status
completed

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

Study Start

First participant enrolled

September 15, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 16, 2019

Last Update Submit

October 18, 2019

Conditions

Mechanically Ventilated Patients

Keywords

clustered nursing interventions

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 14 days

Study Arms (2)

low intervention group

from 0-7 clustered nursing intervention

high intervention group

from 8-15 clustered nursing intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • adult patients of both sex, aged 18 years and over
  • mechanically ventilated for ≥ 48 hours.

You may not qualify if:

  • lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS)
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, critical care medicine

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 22, 2019

Study Start

September 15, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

October 22, 2019

Record last verified: 2019-10