Acute Respiratory Failure Post Surgical (Diagnosis)NCT04877353
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
A study testing NIV in people with Acute Respiratory Failure Post Surgical (Diagnosis), run by South Valley University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Failure Post Surgical (Diagnosis)
- What is being tested?
- NIV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 15 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- NIV
- Keywords
- noninvasive ventilation, COPD, acute respiratory failure
- Medical subject headings
- Disease, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
| Study group | Role | What they receive |
|---|---|---|
| Group N | Experimental | 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery Receives: Device: NIV |
| group C | No intervention | 50 patients recieved conventional oxygen therpy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute respiratory events
patients %
Measured: 28days
Secondary outcomes (5)
acute respiratory failure
patients %
Measured: 28 days
intubation rate
patients %
Measured: 28 days
ICU mortality
patients %
Measured: 28 days
ICU length of stay
days
Measured: 28 days
infectious and non infectious complications
patients %
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jan 2019
- Primary completion30 Mar 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure Post Surgical (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Postoperative NIV
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877353
- Sponsor's protocol ID
- NIV _COPD
- Status last verified
- May 2021
- First submitted
- 29 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT04877353
- Acronym / sponsor ID
- NIV _COPD
- Keywords
- noninvasive ventilation, COPD, acute respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Postoperative NIV
| Arm | Type | Receives |
|---|---|---|
| Group N | Experimental | Device: NIV50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery |
| group C | No intervention | –50 patients recieved conventional oxygen therpy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIVNIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery | Device | Group N |
Primary outcome
acute respiratory events
Time frame: 28days
patients %
5 secondary outcomes
acute respiratory failure
Time frame: 28 days
intubation rate
Time frame: 28 days
ICU mortality
Time frame: 28 days
ICU length of stay
Time frame: 28 days
infectious and non infectious complications
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV in people with Acute Respiratory Failure Post Surgical (Diagnosis), run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute respiratory events (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.