Postoperative Noninvasive Ventilation After Upper Abdomin... | NCT04877353

Studies
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

NCT04877353

Sponsor

South Valley University

Status

Completed

Last Update Posted

May 7, 2021Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Acute Respiratory Failure Post Surgical (Diagnosis)

Interventions

Countries

Egypt

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

May 2021

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

Jan 1, 2019Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

Nov 15, 2020Actual

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

May 3, 2021

First Posted Date

May 7, 2021Actual

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

May 3, 2021

Last Update Posted Date

May 7, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asmaa Mohamed, PhD candidate _anesthesia ,ICU &pain management_Qena SVU, South Valley UniversityPrincipal Investigator

Lead Sponsor

South Valley UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group N	Experimental	50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery	Device: NIV
group C	No Intervention	50 patients recieved conventional oxygen therpy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIV	Device	NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery	Group N

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute respiratory events	patients %	28days

Secondary Outcomes

Measure	Description	Time Frame
acute respiratory failure	patients %	28 days
intubation rate	patients %	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:
- Age˃18 years, scheduled for upper abdominal surgery under general anesthesia.
- Moderate to very severe COPD (GOLD II to IV).
- ASA functional status II or greater.
Exclusion criteria:
- Contraindications to the application of NIV.
- Sleep apnea syndrome.
- Facial deformation.
- Inability to follow the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
asmaa Mostafa		Luxor		85951	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided