NCT04877353

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

April 29, 2021

Last Update Submit

May 3, 2021

Conditions

Acute Respiratory Failure Post Surgical (Diagnosis)

Keywords

noninvasive ventilationCOPDacute respiratory failure

Outcome Measures

Primary Outcomes (1)

  • acute respiratory events

    patients %

    28days

Secondary Outcomes (5)

  • acute respiratory failure

    28 days

  • intubation rate

    28 days

  • ICU mortality

    28 days

  • ICU length of stay

    28 days

  • infectious and non infectious complications

    28 days

Study Arms (2)

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

NIVDEVICE

NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery

Group N

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindications to the application of NIV.
  • Sleep apnea syndrome.
  • Facial deformation.
  • Inability to follow the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

asmaa Mostafa

Luxor, 85951, Egypt

Location

MeSH Terms

Conditions

DiseasePulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Postoperative NIV
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate anesthesia ,ICU &pain management Qena SVU

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 7, 2021

Study Start

January 1, 2019

Primary Completion

March 30, 2020

Study Completion

November 15, 2020

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)