Pulmonary AtelectasisNCT05494255
The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis
A study testing Recruitment maneuver in people with Pulmonary Atelectasis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- Recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2022to 4 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Laporoscopic nephrectomy patients who will be operated in lateral positions
- Elective, semi-elective surgeries
Who cannot join
- Patients with emphysema
- Patients with documanted heart failure
- Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
- Patients with hemodynamic instability
- Patients with pneumothorax risk
- Emergency surgery
- Patients requiring intraoperative liberal fluid therapy (>10 cc/kg/hr)
- Patients requiring blood products
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine
Istanbul
About this study
Official title: The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries
Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM.
There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are:
Read more
T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room
LUS evaluation will be made at 3 different time points in control group (Group NoRM):
T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room.
The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group.
Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.
- Conditions
- Pulmonary Atelectasis
- Being tested
- Recruitment 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.
Recruitment maneuverOther
In Group RM (intervention group) after skin closure, mechanical ventilation settings will be set to FiO2:100%, I:E=1:1, respiratory rate: 6, and then tidal volume will be increased gradually by 150 ml until reaching a plato pressure of 30 mmHg. After 3 breaths in this state, RM will be considered accomplished. LUS evaluation will be made just before and after the RM.
| Study group | Role | What they receive |
|---|---|---|
| Group RM | Active comparator | One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation Receives: Other: Recruitment maneuver |
| Group NoRM | No intervention | Usual care will be applied in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the pre-extubation LUS scores (T3)
Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
Measured: Up to 4 hours
Secondary outcomes (7)
Comparison of recovery room LUS scores (T4)
Lung ultrasound will be applied at post-extubation 30th minute to evaluate the compare the groups for the possible effect of single RM. To obtain LUS score; each lobe is examined on 6 different areas which are scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
Measured: Up to 4.5 hours
Comparison of recovery room PaO2
Arterial blood gas will be analyzed at post-extubation 30th minute along with LUS to observe the effect of RM on oxygenation
Measured: Up to 4.5 hours
The effect of deltaLUS (T3-T2) on oxygenation
DeltaLUS values will be analyzed for relation with post-extubation 30th min PaO2 values.
Measured: Up to 4.5 hours
Length of stay in post anesthesia care unit (PACU)
The duration required for the patient to stay in PACU (minutes)
Measured: Up to 4 hours
Length of stay in hospital
The duration required for patient to stay in hospital (days)
Measured: Up to 2 weeks
Postoperative respiratory complications
Incidence of mild-to-severe respiratory failure, pneumothorax, ALI, ARDS, bronchospasm, pneumonia
Measured: Up to 5 days
Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications
Sensitivity and specifity (Area under the curve-ROC analysis) values of LUS score of dependant lung. (0=the best condition of the dependant lung, 18=the worst condition of the dependant lung with consolidation and atelectasis)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start11 Aug 2022
- Primary completion2 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Sertaç Bingül, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494255
- Sponsor's protocol ID
- 2022/1066
- Status last verified
- May 2023
- First submitted
- 6 Aug 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries
- ClinicalTrials.gov ID
- NCT05494255
- Acronym / sponsor ID
- 2022/1066
- Conditions
- Pulmonary Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 9 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.
Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM.
There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are:
T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room
LUS evaluation will be made at 3 different time points in control group (Group NoRM):
T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room.
The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group.
Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group RM | Active comparator | Other: Recruitment maneuverOne single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation |
| Group NoRM | No intervention | –Usual care will be applied in this group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- Laporoscopic nephrectomy patients who will be operated in lateral positions
- Elective, semi-elective surgeries
Key exclusion criteria (8 listed)
- Patients with emphysema
- Patients with documanted heart failure
- Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
- Patients with hemodynamic instability
- Patients with pneumothorax risk
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 |
|---|---|---|
| Recruitment maneuverIn Group RM (intervention group) after skin closure, mechanical ventilation settings will be set to FiO2:100%, I:E=1:1, respiratory rate: 6, and then tidal volume will be increased gradually by 150 ml until reaching a plato pressure of 30 mmHg. After 3 breaths in this state, RM will be considered accomplished. LUS evaluation will be made just before and after the RM. | Other | Group RM |
Primary outcome
Comparison of the pre-extubation LUS scores (T3)
Time frame: Up to 4 hours
Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
7 secondary outcomes
Comparison of recovery room LUS scores (T4)
Time frame: Up to 4.5 hours
Comparison of recovery room PaO2
Time frame: Up to 4.5 hours
The effect of deltaLUS (T3-T2) on oxygenation
Time frame: Up to 4.5 hours
Length of stay in post anesthesia care unit (PACU)
Time frame: Up to 4 hours
Length of stay in hospital
Time frame: Up to 2 weeks
Postoperative respiratory complications
Time frame: Up to 5 days
Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications
Time frame: Up to 24 hours
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 6 May 2023.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request
Related trials for Pulmonary Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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 Recruitment maneuver in people with Pulmonary Atelectasis, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 6 May 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 Turkey (Türkiye). 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?
Comparison of the pre-extubation LUS scores (T3) (time frame: Up to 4 hours). 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 6 May 2023.