Mechanical Ventilation ComplicationNCT05483959
BIPAP in the Management of Acute Respiratory Distress Syndrome
A study testing BIPAP mode/SIMV PC mode in people with Mechanical Ventilation Complication, run by South Valley University at 1 site in Egypt.
Trial summary
Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- BIPAP mode/SIMV PC mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2019to 22 Jul 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated Adult ARDS patients
- ARDS is diagnosed according to berlin criteria.
Who cannot join
- Age < 18 years.
- Cardiac or respiratory arrest on admission.
- Morbid obesity with BMI > 40.
- Acute exacerbation of IPF.
- Cerebrovascular or neuro muscular disorder. 6. Diabetic ketoacidosis. 7. Hepatic or renal disease. 8.Cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study
Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.
Read the detailed description
Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the time-cycled switching between two set pressure levels. In the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation.
A proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.
ARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance.
In patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- BIPAP mode/SIMV PC mode
- Keywords
- BIPAP , ARDS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIPAP mode/SIMV PC modeOther
BIPAP is a mode of ventilation recently used in ARDS
| Study group | Role | What they receive |
|---|---|---|
| BIPAP group | Experimental | Mechanically ventilated ARDS patients on BIPAP mode of ventilation Receives: Other: BIPAP mode/SIMV PC mode |
| SIMV PC group | Experimental | Mechanically ventilated ARDS patients on SIMV PC mode of ventilation Receives: Other: BIPAP mode/SIMV PC mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared
Base line oxygen saturation of BIPAP group and SIMV PC group patients will be taken from the arterial blood gases and recorded from the range of oxygen saturation from 90 to 98% and will be compared between both groups
Measured: Baseline
Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device
Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device and will be compared between both groups according to the normal range of systolic blood pressure from 90mmHg to 130mmHg and diastolic blood pressure from the range of 60 mmHg to 90 mmHg
Measured: Base line
Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and recorded
Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and compared between both groups according to the range of tidal volume from 4 to 8 ml per kg ideal body weight
Measured: 24 hours after mechanical ventilation
Secondary outcomes (2)
Duration of mechanical ventilation of BIPAP group
The duration of mechanical ventilation duration had been compared between both groups
Measured: 6 weeks
The duration of anesthesia in days
The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start20 Apr 2019
- Primary completion30 Nov 2021
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Sayed Salem, South Valley University
- Investigators
- Khaled H Ahmed, Professor, Study director, Assiut UniversityAlaa R Mahmoud, Professor, Principal investigator, faculty of medicine, South Valley UniversityGad S Gad, Professor, Study chair, faculty of medicine, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483959
- Sponsor's protocol ID
- BIPAP IN ARDS
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Hedenstierna G, Lattuada M. Gas exchange in the ventilated patient. Curr Opin Crit Care. 2002 Feb;8(1):39-44. doi: 10.1097/00075198-200202000-00007.
PubMed 12205405Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.
PubMed 8143712
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study
- ClinicalTrials.gov ID
- NCT05483959
- Acronym / sponsor ID
- BIPAP IN ARDS
- Conditions
- Mechanical Ventilation Complication
- Keywords
- BIPAP , ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 2 Aug 2022 (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.
Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.
Detailed description
Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the time-cycled switching between two set pressure levels. In the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation.
A proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.
ARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance.
In patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
| Arm | Type | Receives |
|---|---|---|
| BIPAP group | Experimental | Other: BIPAP mode/SIMV PC modeMechanically ventilated ARDS patients on BIPAP mode of ventilation |
| SIMV PC group | Experimental | Other: BIPAP mode/SIMV PC modeMechanically ventilated ARDS patients on SIMV PC mode of ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All intubated Adult ARDS patients
- ARDS is diagnosed according to berlin criteria.
Key exclusion criteria (5 listed)
- Age < 18 years.
- Cardiac or respiratory arrest on admission.
- Morbid obesity with BMI > 40.
- Acute exacerbation of IPF.
- Cerebrovascular or neuro muscular disorder. 6. Diabetic ketoacidosis. 7. Hepatic or renal disease. 8.Cardiac disease.
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 |
|---|---|---|
| BIPAP mode/SIMV PC modeBIPAP is a mode of ventilation recently used in ARDS | Other | BIPAP group, SIMV PC group |
Primary outcome
Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared
Time frame: Baseline
Base line oxygen saturation of BIPAP group and SIMV PC group patients will be taken from the arterial blood gases and recorded from the range of oxygen saturation from 90 to 98% and will be compared between both groups
Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device
Time frame: Base line
Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device and will be compared between both groups according to the normal range of systolic blood pressure from 90mmHg to 130mmHg and diastolic blood pressure from the range of 60 mmHg to 90 mmHg
Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and recorded
Time frame: 24 hours after mechanical ventilation
Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and compared between both groups according to the range of tidal volume from 4 to 8 ml per kg ideal body weight
2 secondary outcomes
Duration of mechanical ventilation of BIPAP group
Time frame: 6 weeks
The duration of anesthesia in days
Time frame: 2 weeks
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 2 Aug 2022.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 12205405Hedenstierna G, Lattuada M. Gas exchange in the ventilated patient. Curr Opin Crit Care. 2002 Feb;8(1):39-44. doi: 10.1097/00075198-200202000-00007.
- Results publication: PubMed 8143712Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.
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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.
Khaled H Ahmed, Professor study director
Assiut University
Alaa R Mahmoud, Professor principal investigator
faculty of medicine, South Valley University
Gad S Gad, Professor study chair
faculty of medicine, South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIPAP mode/SIMV PC mode in people with Mechanical Ventilation Complication, 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?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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 2 Aug 2022. 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?
Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483959, which also lists 3 linked publications.
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 2 Aug 2022.