Effect Of Clustered Nursing Interventions On Physiologica... | NCT04134481

Studies
Effect Of Clustered Nursing Interventions On Physiological Response In Critically Ill Patients

NCT04134481

Sponsor

Alexandria University

Status

Completed

Last Update Posted

Oct 22, 2019Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Mechanically Ventilated Patients

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2015Actual

Primary Completion Date

Apr 1, 2016Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Oct 16, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low intervention group		from 0-7 clustered nursing intervention
high intervention group		from 8-15 clustered nursing intervention

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample