Mechanical Ventilation During AnesthesiaNCT04704596
Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery
A study testing anesthesia ventilator machine and lung ultrasound in people with Mechanical Ventilation During Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Ventilation During Anesthesia
- What is being tested?
- anesthesia ventilator machine and lung ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Dec 2020to 20 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- physical status American Society of Anesthesiologist(ASA) I or II
Who cannot join
- Patients refuse ASA physical status more > II
- Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and significant cardiac dysfunction.
- Patients with pulmonary hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery, Randomized Clinical Trial
The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.
- Conditions
- Mechanical Ventilation During Anesthesia
- Being tested
- anesthesia ventilator machine, lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia ventilator machineDevice
dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment
lung ultrasoundDevice
lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment
| Study group | Role | What they receive |
|---|---|---|
| dynamic lung compliance for detection of optimum PEEP | Active comparator | detection of optimum PEEP by measurement of the dynamic lung compliance (by the ventilator machine) after lung recruitment Receives: Device: anesthesia ventilator machine |
| Lung ultrasound for detection of the optimum PEEP | Active comparator | Lung ultrasound will be used to detect the optimum PEEP after lung recruitment Receives: Device: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of the optimum PEEP which is measured in mmHg
the optimum PEEP will be detected after alveolar recruitment either by dynamic lung compliance or by lung ultarsound views
Measured: intraoperative period
Secondary outcomes (1)
prevention of postoperative pulmonary complications
patients will be monitored for detection of postoperative pulmonary complictaios as atelectasis , pneumothorax , respiratory failure
Measured: 1st 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start16 Dec 2020
- Primary completion15 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation During AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704596
- Sponsor's protocol ID
- FMASU R 127/2020
- Status last verified
- Jul 2022
- First submitted
- 7 Jan 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04704596
- Acronym / sponsor ID
- FMASU R 127/2020
- Conditions
- Mechanical Ventilation During Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 11 Jan 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.
The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dynamic lung compliance for detection of optimum PEEP | Active comparator | Device: anesthesia ventilator machinedetection of optimum PEEP by measurement of the dynamic lung compliance (by the ventilator machine) after lung recruitment |
| Lung ultrasound for detection of the optimum PEEP | Active comparator | Device: lung ultrasoundLung ultrasound will be used to detect the optimum PEEP after lung recruitment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physical status American Society of Anesthesiologist(ASA) I or II
Key exclusion criteria (3 listed)
- Patients refuse ASA physical status more > II
- Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and significant cardiac dysfunction.
- Patients with pulmonary hypertension.
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 |
|---|---|---|
| anesthesia ventilator machinedynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment | Device | dynamic lung compliance for detection of optimum PEEP |
| lung ultrasoundlung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment | Device | Lung ultrasound for detection of the optimum PEEP |
Primary outcome
detection of the optimum PEEP which is measured in mmHg
Time frame: intraoperative period
the optimum PEEP will be detected after alveolar recruitment either by dynamic lung compliance or by lung ultarsound views
1 secondary outcome
prevention of postoperative pulmonary complications
Time frame: 1st 24 hour
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 8 Jul 2022.
- Individual participant dataSharing planned: Yes
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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 anesthesia ventilator machine and lung ultrasound in people with Mechanical Ventilation During Anesthesia, run by Ain Shams 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 1 inclusion and 3 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 8 Jul 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?
detection of the optimum PEEP which is measured in mmHg (time frame: intraoperative period). 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 8 Jul 2022.