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

Primary Purpose

Acute Respiratory Failure Post Surgical (Diagnosis)

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
NIV
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Failure Post Surgical (Diagnosis) focused on measuring noninvasive ventilation, COPD, acute respiratory failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  1. 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.

  2. Exclusion criteria:

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

Sites / Locations

  • asmaa Mostafa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group N

group C

Arm Description

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

50 patients recieved conventional oxygen therpy.

Outcomes

Primary Outcome Measures

acute respiratory events
patients %

Secondary Outcome Measures

acute respiratory failure
patients %
intubation rate
patients %
ICU mortality
patients %
ICU length of stay
days
infectious and non infectious complications
patients %

Full Information

First Posted
April 29, 2021
Last Updated
May 3, 2021
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04877353
Brief Title
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
Official Title
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure Post Surgical (Diagnosis)
Keywords
noninvasive ventilation, COPD, acute respiratory failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Postoperative NIV
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group N
Arm Type
Experimental
Arm Description
50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
Arm Title
group C
Arm Type
No Intervention
Arm Description
50 patients recieved conventional oxygen therpy.
Intervention Type
Device
Intervention Name(s)
NIV
Intervention Description
NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
Primary Outcome Measure Information:
Title
acute respiratory events
Description
patients %
Time Frame
28days
Secondary Outcome Measure Information:
Title
acute respiratory failure
Description
patients %
Time Frame
28 days
Title
intubation rate
Description
patients %
Time Frame
28 days
Title
ICU mortality
Description
patients %
Time Frame
28 days
Title
ICU length of stay
Description
days
Time Frame
28 days
Title
infectious and non infectious complications
Description
patients %
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
asmaa Mostafa
City
Luxor
ZIP/Postal Code
85951
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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