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

• Sponsor: South Valley University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04877353
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.5
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure Post Surgical (Diagnosis)	Device: NIV	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Postoperative NIVPostoperative NIV
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Nov 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. acute respiratory events [28days]

   patients %

Secondary Outcome Measures

1. acute respiratory failure [28 days]

   patients %

2. intubation rate [28 days]

   patients %

3. ICU mortality [28 days]

   patients %

4. ICU length of stay [28 days]

   days

5. infectious and non infectious complications [28 days]

   patients %

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Exclusion criteria:

• Contraindications to the application of NIV.

• Sleep apnea syndrome.

• Facial deformation.

• Inability to follow the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	asmaa Mostafa	Luxor		Egypt	85951

Sponsors and Collaborators

• South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asmaa Mohamed, PhD candidate _anesthesia ,ICU &pain management_Qena SVU, South Valley University
• ClinicalTrials.gov Identifier: NCT04877353
• Other Study ID Numbers: NIV _COPD
• First Posted: May 7, 2021
• Last Update Posted: May 7, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Asmaa Mohamed, PhD candidate _anesthesia ,ICU &pain management_Qena SVU, South Valley University: noninvasive ventilation; COPD; acute respiratory failure
• Additional relevant MeSH terms: Lung Diseases; Respiratory Insufficiency; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of May 7, 2021