Anesthesia Induced AtelectasisNCT04872361
Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?
A study testing Low PEEP, High PEEP and High PEEP/RM in people with Anesthesia Induced Atelectasis, run by Mansoura University at 1 site in Egypt.
Trial summary
Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia Induced Atelectasis
- What is being tested?
- Low PEEP, High PEEP and High PEEP/RM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to Oct 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
- American Society of Anesthesiologists' physical status grades I, II, and III.
Who cannot join
- Patient refusal.
- Psychiatric diseases.
- Body Mass Index > 35 Kg/m2.
- Previous intrathoracic procedures.
- History of severe obstructive pulmonary disease.
- History of severe restrictive lung disease.
- Pulmonary arterial hypertension ( systolic pulmonary arterial pressure >40 mmHg).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies
Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.
Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.
Read the detailed description
The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.
Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.
A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography
- Conditions
- Anesthesia Induced Atelectasis
- Being tested
- Low PEEP, High PEEP, High PEEP/RM, Lung ultrasonogrphy assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low PEEPProcedure or surgery
Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study
High PEEPProcedure or surgery
PEEP of 10 cm H2O will be applied
High PEEP/RMProcedure or surgery
PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence
Lung ultrasonogrphy assessmentDevice
The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines
- three or more B lines
- coalescent B lines
- consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss
| Study group | Role | What they receive |
|---|---|---|
| Low PEEP | Placebo comparator | Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM) Receives: Procedure: Low PEEP; Device: Lung ultrasonogrphy assessment |
| High PEEP | Active comparator | High positive end-expiratory pressure (PEEP) Receives: Procedure: High PEEP; Device: Lung ultrasonogrphy assessment |
| High PEEP/RM | Active comparator | High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM) Receives: Procedure: High PEEP/RM; Device: Lung ultrasonogrphy assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-emergence LUS score
Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.
Measured: intraoperative before recovery from anesthesia
Secondary outcomes (10)
Lung ultrasonography score (LUS score)
Lung ultrasonography score (LUS score) between groups
Measured: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Heart rate
heart rate between groups at each time point of LUS score performance
Measured: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Mean blood pressure
mean arterial blood pressure between groups at each time point of LUS score performance
Measured: preoperative, intraoperative to 1 hour postoperative
oxygen saturation
patient oxygen saturation between groups at each time point of LUS score performance
Measured: preoperative, intraoperative to 1 hour postoperative
End-tidal carbon dioxide tension
end tidal CO2 between groups post induction, post recruitment and before extubation
Measured: intraoperative for anesthesia duration
Arterial partial pressure of oxygen (PaO2)
arterial blood gases post induction, before extubation and at the PACU
Measured: Intraoperative and 15 min postoperative
Arterial partial pressure of carbon dioxide (PaCO2)
arterial blood gases post induction, before extubation and at the PACU
Measured: Intraoperative and 15 min postoperative
PaO2/FiO2
arterial blood gases post induction, before extubation and at the PACU
Measured: Intraoperative and 15 min postoperative
Peak inspiratory pressure
peak inspiratory pressure between groups after intubation
Measured: intraoperative for anesthesia duration
Postoperative pulmonary complications (PPCs)
PPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 May 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Induced AtelectasisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aboelnour E Badran, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareHanaa M EL- Bendary, MD, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872361
- Sponsor's protocol ID
- MFM-IRB.MD.21.01.412
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be available after completing the study and acceptance for publication
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies
- ClinicalTrials.gov ID
- NCT04872361
- Acronym / sponsor ID
- MFM-IRB.MD.21.01.412
- Conditions
- Anesthesia Induced Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 4 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.
Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.
Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.
Detailed description
The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.
Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.
A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low PEEP | Placebo comparator | Procedure: Low PEEP, Device: Lung ultrasonogrphy assessmentLow positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM) |
| High PEEP | Active comparator | Procedure: High PEEP, Device: Lung ultrasonogrphy assessmentHigh positive end-expiratory pressure (PEEP) |
| High PEEP/RM | Active comparator | Procedure: High PEEP/RM, Device: Lung ultrasonogrphy assessmentHigh positive end-expiratory pressure (PEEP) and recruitment maneuver (RM) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists' physical status grades I, II, and III.
Key exclusion criteria (8 listed)
- Patient refusal.
- Psychiatric diseases.
- Body Mass Index > 35 Kg/m2.
- Previous intrathoracic procedures.
- History of severe obstructive pulmonary 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 |
|---|---|---|
| Low PEEPPatients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study | Procedure or surgery | Low PEEP |
| High PEEPPEEP of 10 cm H2O will be applied | Procedure or surgery | High PEEP |
| High PEEP/RMPEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence | Procedure or surgery | High PEEP/RM |
| Lung ultrasonogrphy assessmentThe thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines 1. three or more B lines 2. coalescent B lines 3. consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss | Device | High PEEP, High PEEP/RM, Low PEEP |
Primary outcome
Pre-emergence LUS score
Time frame: intraoperative before recovery from anesthesia
Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.
10 secondary outcomes
Lung ultrasonography score (LUS score)
Time frame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Heart rate
Time frame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
Mean blood pressure
Time frame: preoperative, intraoperative to 1 hour postoperative
oxygen saturation
Time frame: preoperative, intraoperative to 1 hour postoperative
End-tidal carbon dioxide tension
Time frame: intraoperative for anesthesia duration
Arterial partial pressure of oxygen (PaO2)
Time frame: Intraoperative and 15 min postoperative
Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: Intraoperative and 15 min postoperative
PaO2/FiO2
Time frame: Intraoperative and 15 min postoperative
Peak inspiratory pressure
Time frame: intraoperative for anesthesia duration
Postoperative pulmonary complications (PPCs)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Yes. will be available after completing the study and acceptance for publication
Related trials for Anesthesia Induced Atelectasis
Recruiting
Open Lung Protective Extubation Following General Anesthesia
Intra-abdominal Surgery, Anesthesia
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
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.
Aboelnour E Badran, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Hanaa M EL- Bendary, MD study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low PEEP, High PEEP and High PEEP/RM in people with Anesthesia Induced Atelectasis, run by Mansoura 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 8 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: status not confirmed, as of the sponsor's last update on 4 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pre-emergence LUS score (time frame: intraoperative before recovery from anesthesia). 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 4 May 2021.