Alveolar Recruitment ManeuversNCT05720351
Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
A study testing Lachmann maneuver and Staircase maneuver in people with Alveolar Recruitment Maneuvers and Atelectasis, run by Tanta University at 1 site in Egypt.
Trial summary
The study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alveolar Recruitment Maneuvers, Atelectasis, Bariatric Surgery
- What is being tested?
- Lachmann maneuver and Staircase maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 10 Aug 2023
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult morbidly obese patients (Body mass index < 40kg / m2 or Body mass index < 35kg / m2 with obesity-related comorbidities such as hypertension, diabetes, and sleep apnea)
- undergo elective bariatric laparoscopic surgery with an expected duration of at least one hour under general anesthesia.
Who cannot join
- Patient refusal to participate in the study.
- Patients with a previous history of thoracic surgery.
- Patients with a history of chest disease (COPD, emphysema, or pneumothorax).
- Patients with abnormal pre-operative chest radiographs such as pneumonia, pleural effusion.
- Patients with heart failure or impending failure.
- Patients with known hypovolemia.
- Patients with increased intracranial pressure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alaa Mohsen Shahien
Tanta, ElGharbiaa, 31511
Alaa M Shahien, MD, +20155 5957744 ext. +20, alaa162094_pg@med.tanta.edu.eg
About this study
Official title: Comparison Between Two Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
The study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery
Read the detailed description
Weight loss surgery, often known as bariatric surgery, is an effective obesity treatment. Most people undergoing such surgery may show an improvement in, or the resolution of, conditions such as diabetes, dyslipidemia, hypertension, and obstructive sleep apnea.
Currently, there is no standard ventilation strategy has been established for obese patients. However, there is some evidence that recruitment maneuvers (RM) combined with protective lung ventilation strategy improve oxygenation and compliance compared to other strategies.
Alveolar recruitment maneuver refers to the periodic hyperinflation of the lungs that has been utilized to open up the lung and keep the lung open in anesthetized patients. The use of recruitment maneuvers has been shown to reduce the incidence and extent of atelectasis during general anesthesia by different methods.
Lung ultrasonography is considered a useful tool in perioperative care. Recent research showed that lung ultrasound could assess lung aeration and diagnose anesthesia-induced atelectasis accurately in the perioperative period by measuring the extent of atelectasis by the scoring system; also, the response to recruitment manoeuver for each patient can be evaluated easily. Thus, it has great potential as a bedside non-invasive, sensitive tool for guiding effective recruitment manoeuvers to reduce the formation of pulmonary atelectasis in the surgical setting
- Being tested
- Lachmann maneuver, Staircase maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lachmann maneuverProcedure or surgery
Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds)
Staircase maneuverProcedure or surgery
Patients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point
| Study group | Role | What they receive |
|---|---|---|
| Lachmann maneuver | Active comparator | Patients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds) Receives: Procedure: Lachmann maneuver |
| Staircase maneuver | Active comparator | Patients undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point Receives: Procedure: Staircase maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Lung ultrasound score.
Access lung ultrasound score at the end of surgery
Measured: 48 hours postoperatively
Secondary outcomes (3)
Access Pulmonary complications
Pulmonary complications were measured as (pneumonia, pulmonary edema, pleural effusion, and pneumothorax).
Measured: 48 hours postoperatively
Access incidence of oxygen desaturation
incidence of oxygen desaturation was measured
Measured: 48 hours Postoperatively
Access Complications of recruitment maneuver
Complications of recruitment maneuver including bradycardia, hypotension were measured
Measured: 48 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start10 Aug 2023 (estimated)
- Primary completion10 Aug 2023 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Recruitment ManeuversStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohsen Shahien, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720351
- Sponsor's protocol ID
- 35292\2\22
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score
- ClinicalTrials.gov ID
- NCT05720351
- Acronym / sponsor ID
- 35292\2\22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 10 Aug 2023 (estimated)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 9 Feb 2023 (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 study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery
Detailed description
Weight loss surgery, often known as bariatric surgery, is an effective obesity treatment. Most people undergoing such surgery may show an improvement in, or the resolution of, conditions such as diabetes, dyslipidemia, hypertension, and obstructive sleep apnea.
Currently, there is no standard ventilation strategy has been established for obese patients. However, there is some evidence that recruitment maneuvers (RM) combined with protective lung ventilation strategy improve oxygenation and compliance compared to other strategies.
Alveolar recruitment maneuver refers to the periodic hyperinflation of the lungs that has been utilized to open up the lung and keep the lung open in anesthetized patients. The use of recruitment maneuvers has been shown to reduce the incidence and extent of atelectasis during general anesthesia by different methods.
Lung ultrasonography is considered a useful tool in perioperative care. Recent research showed that lung ultrasound could assess lung aeration and diagnose anesthesia-induced atelectasis accurately in the perioperative period by measuring the extent of atelectasis by the scoring system; also, the response to recruitment manoeuver for each patient can be evaluated easily. Thus, it has great potential as a bedside non-invasive, sensitive tool for guiding effective recruitment manoeuvers to reduce the formation of pulmonary atelectasis in the surgical setting
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lachmann maneuver | Active comparator | Procedure: Lachmann maneuverPatients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds) |
| Staircase maneuver | Active comparator | Procedure: Staircase maneuverPatients undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult morbidly obese patients (Body mass index < 40kg / m2 or Body mass index < 35kg / m2 with obesity-related comorbidities such as hypertension, diabetes, and sleep apnea)
- undergo elective bariatric laparoscopic surgery with an expected duration of at least one hour under general anesthesia.
Key exclusion criteria (7 listed)
- Patient refusal to participate in the study.
- Patients with a previous history of thoracic surgery.
- Patients with a history of chest disease (COPD, emphysema, or pneumothorax).
- Patients with abnormal pre-operative chest radiographs such as pneumonia, pleural effusion.
- Patients with heart failure or impending failure.
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 |
|---|---|---|
| Lachmann maneuverPatients undergone the Lachmann recruitment maneuver (30 CmH2O PEEP for 30 seconds) | Procedure or surgery | Lachmann maneuver |
| Staircase maneuverPatients undergone Undergone staircase recruitment maneuver (stepped increase in PEEP by 2 CmH2O every five breaths until reach upper deflection point | Procedure or surgery | Staircase maneuver |
Primary outcome
Improvement of Lung ultrasound score.
Time frame: 48 hours postoperatively
Access lung ultrasound score at the end of surgery
3 secondary outcomes
Access Pulmonary complications
Time frame: 48 hours postoperatively
Access incidence of oxygen desaturation
Time frame: 48 hours Postoperatively
Access Complications of recruitment maneuver
Time frame: 48 hours Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
Related trials for Alveolar Recruitment Maneuvers
Enrolling by invitation
Optimal Interval for Periodic Alveolar Recruitment Maneuvers Achieving 90% Lung Re-expansion During Intraoperative Ventilation
Major Abdominal Surgery, Atelectasis
Not yet recruitingObservational study
Prevention of Postoperative Respiratory Complications
General Anesthesia, Ventilator-Induced Lung Injuries
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lachmann maneuver and Staircase maneuver in people with Alveolar Recruitment Maneuvers and Atelectasis, run by Tanta 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 7 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 9 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Shahien, MD (+201555957744 ext. +20, alaa162094_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Lung ultrasound score. (time frame: 48 hours postoperatively). 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 9 Feb 2023.