Atelectasis, Postoperative PulmonaryNCT04269564
Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound
A study testing stepwise PEEP in people with Atelectasis, Postoperative Pulmonary, run by Cairo University at 1 site in Egypt.
Trial summary
Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting. in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary
- What is being tested?
- stepwise PEEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2020to 19 Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- they are between 18 and 65 years of age
- BMI more than 35
- patients with normal respiratory functions
- ASA 1 or 2
Who cannot join
- Previous lung surgery
- Bronchial asthma
- Contralateral lung bullae 4. Uncompensated cardiac disease (NYHA class 3 or 4) 5. Obstructive or restrictive lung disease 6. Patients on home oxygen therapy 7. Hemodynamic instability and increased intracranial pressure 8. In adittion , any patient who developes hemodynamic instability (MAP <60mmHg) or hypoxia (Po2 less than 60) during the study will excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Use of Intraoperative Bedside Lung Ultrasound in Optimizing "Positive End Expiratory Pressure"PEEP in Patients Undergoing Laparoscopic Bariatric Surgeries
Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.
in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.
- Conditions
- Atelectasis, Postoperative Pulmonary
- Being tested
- stepwise PEEP
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepwise PEEPDevice
- a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs.
- Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery.
We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2.
| Study group | Role | What they receive |
|---|---|---|
| group A | No intervention | Group A patients received the standard ventilation protocol as follows: volume-controlled ventilation mode, with VT 6 ml/kg of ideal body weight, inspiratory : expiratory ratio 1 : 2, a PEEP of 4 cmH2O, and respiratory rate 10-12 breaths/min that will be adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mmHg and inspired oxygen fraction of 0.5. |
| group B | Active comparator | Patients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation. Receives: Device: stepwise PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of lung ultrasound in optimizing peep
to evaluate the effect of lung ultrasound in optimizing peep in obese patients undergoing laparoscopic surgeries on the Incidence of intraoperative hypoxia and atlectasis
Measured: intraoperative and early postoperative first 24 hours after recovery from anaesthesia
Secondary outcomes (1)
effect on early postoperative oxygenation
Evaluating the effect of stepwise PEEP approach on the incidence of early postoperative in the first 24 hours atelectasis and oxygenation.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start20 Feb 2020
- Primary completion18 Aug 2020
- Study completion19 Aug 2020
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 Atelectasis, Postoperative PulmonaryStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdel ghany ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269564
- Sponsor's protocol ID
- MS-263-2019
- Status last verified
- Aug 2020
- First submitted
- 3 Feb 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
PubMed 30253139Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
PubMed 29430443Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
PubMed 27669555
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Use of Intraoperative Bedside Lung Ultrasound in Optimizing "Positive End Expiratory Pressure"PEEP in Patients Undergoing Laparoscopic Bariatric Surgeries
- ClinicalTrials.gov ID
- NCT04269564
- Acronym / sponsor ID
- MS-263-2019
- Conditions
- Atelectasis, Postoperative Pulmonary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 17 Feb 2020 (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.
Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.
in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | No intervention | –Group A patients received the standard ventilation protocol as follows: volume-controlled ventilation mode, with VT 6 ml/kg of ideal body weight, inspiratory : expiratory ratio 1 : 2, a PEEP of 4 cmH2O, and respiratory rate 10-12 breaths/min that will be adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mmHg and inspired oxygen fraction of 0.5. |
| group B | Active comparator | Device: stepwise PEEPPatients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- they are between 18 and 65 years of age
- BMI more than 35
- patients with normal respiratory functions
- ASA 1 or 2
Key exclusion criteria (3 listed)
- Previous lung surgery
- Bronchial asthma
- Contralateral lung bullae 4. Uncompensated cardiac disease (NYHA class 3 or 4) 5. Obstructive or restrictive lung disease 6. Patients on home oxygen therapy 7. Hemodynamic instability and increased intracranial pressure 8. In adittion , any patient who developes hemodynamic instability (MAP <60mmHg) or hypoxia (Po2 less than 60) during the study will excluded from the study
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 |
|---|---|---|
| stepwise PEEP* a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs. * Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery. We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2. | Device | group B |
Primary outcome
efficacy of lung ultrasound in optimizing peep
Time frame: intraoperative and early postoperative first 24 hours after recovery from anaesthesia
to evaluate the effect of lung ultrasound in optimizing peep in obese patients undergoing laparoscopic surgeries on the Incidence of intraoperative hypoxia and atlectasis
1 secondary outcome
effect on early postoperative oxygenation
Time frame: 24 hours postoperative
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 20 Aug 2020.
- Background: PubMed 30253139Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
- Background: PubMed 29430443Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
- Background: PubMed 27669555Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
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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 stepwise PEEP in people with Atelectasis, Postoperative Pulmonary, run by Cairo 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 4 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 20 Aug 2020. 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?
efficacy of lung ultrasound in optimizing peep (time frame: intraoperative and early postoperative first 24 hours after recovery from anaesthesia). 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 NCT04269564, 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 20 Aug 2020.