Pulmonary AtelectasisNCT03607240
Ultrasound-guided Alveolar Recruitment in Laparoscopic Gynecological Surgery
A study testing lung ultrasound-guided alveolar recruitment and conventional alveolar recruitment in people with Pulmonary Atelectasis, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The study aims to compare the degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- lung ultrasound-guided alveolar recruitment and conventional alveolar recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Aug 2018to 15 Jan 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled to undergo elective laparoscopic gynecological surgery (laparoscopic ovarian cystectomy or laparoscopic salpingo-oophorectomy or laparoscopic hysterectomy or laparoscopic myomectomy) under general anesthesia, with ASA physical status classification I or II
Who cannot join
- Previous history of lung surgery
- Patients having pneumonia, pneumothorax, or pleural effusion in preoperative chest X-ray
- Patients with COPD, emphysema
- Patients with previous history of pneumothorax, or bullae
- Morbid cardiac disease
- Adolescent aged < 18 years
- Anticipated duration of surgery < 1 hour
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Jin-Tae Kim
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery
The study aims to compare the degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery
- Conditions
- Pulmonary Atelectasis
- Being tested
- lung ultrasound-guided alveolar recruitment, conventional alveolar recruitment
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound-guided alveolar recruitmentProcedure or surgery
Alveolar recruitment maneuver will be performed under lung ultrasound-guidance. Positive pressure will be not exceed 40cmH2O and duration of positive pressure inflation will not exceed 10 seconds.
conventional alveolar recruitmentProcedure or surgery
Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| LUS-guided alveolar recruitment | Experimental | Lung ultrasound-guided alveolar recruitment maneuver will be performed Receives: Procedure: lung ultrasound-guided alveolar recruitment |
| conventional alveolar recruitment | Active comparator | Alveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds. Receives: Procedure: conventional alveolar recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified lung ultrasound score at the end of surgery
Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).
Measured: At the end of surgery
Secondary outcomes (8)
modified lung ultrasound score at post-anesthesia care unit (PACU)
Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).
Measured: intraoperative
incidence of atelectasis diagnosed by ultrasonography
the presence of atelectasis by ultrasonography
Measured: intraoperative
arterial blood gas analyses
PaO2, PaCO2, SaO2, O2 index (PaO2/FiO2)
Measured: intraoperative
incidence of postoperative complications
fever, pneumonia, atelectasis diagnosed by chest X-ray
Measured: during the postoperative period until discharge from hospital, an average of 3 days
intraoperative mean arterial pressure
mean arterial pressure in mmHg
Measured: intraoperative
intraoperative SpO2
SpO2 in %
Measured: intraoperative
intraoperative peak airway pressure
peak airway pressure in cmH2O
Measured: intraoperative
Incidence of postoperative shoulder pain at POD #1
patients will be asked whether they have shoulder pain or not, using NRS (0 to 10) scale
Measured: assessed at postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start6 Aug 2018
- Primary completion10 Jan 2019
- Study completion15 Jan 2019
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 Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607240
- Sponsor's protocol ID
- H-1805-148-948
- Status last verified
- Oct 2019
- First submitted
- 1 Jul 2018
- Last updated
- 18 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monastesse 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 27669555Song IK, Kim EH, Lee JH, Ro S, Kim HS, Kim JT. Effects of an alveolar recruitment manoeuvre guided by lung ultrasound on anaesthesia-induced atelectasis in infants: a randomised, controlled trial. Anaesthesia. 2017 Feb;72(2):214-222. doi: 10.1111/anae.13713. Epub 2016 Nov 2.
PubMed 27804117Park SK, Yang H, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-guided versus conventional lung recruitment manoeuvres in laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(3):275-284. doi: 10.1097/EJA.0000000000001435.
PubMed 33399385
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Alveolar Recruitment on Postoperative Atelectasis in Patients Receiving Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT03607240
- Acronym / sponsor ID
- H-1805-148-948
- Conditions
- Pulmonary Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 31 Jul 2018 (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 degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUS-guided alveolar recruitment | Experimental | Procedure: lung ultrasound-guided alveolar recruitmentLung ultrasound-guided alveolar recruitment maneuver will be performed |
| conventional alveolar recruitment | Active comparator | Procedure: conventional alveolar recruitmentAlveolar recruitment maneuver will be provided with positive pressure of 30 cmH2O for 10 seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled to undergo elective laparoscopic gynecological surgery (laparoscopic ovarian cystectomy or laparoscopic salpingo-oophorectomy or laparoscopic hysterectomy or laparoscopic myomectomy) under general anesthesia, with ASA physical status classification I or II
Key exclusion criteria (7 listed)
- Previous history of lung surgery
- Patients having pneumonia, pneumothorax, or pleural effusion in preoperative chest X-ray
- Patients with COPD, emphysema
- Patients with previous history of pneumothorax, or bullae
- Morbid cardiac 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 |
|---|---|---|
| lung ultrasound-guided alveolar recruitmentAlveolar recruitment maneuver will be performed under lung ultrasound-guidance. Positive pressure will be not exceed 40cmH2O and duration of positive pressure inflation will not exceed 10 seconds. | Procedure or surgery | LUS-guided alveolar recruitment |
| conventional alveolar recruitmentAlveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds | Procedure or surgery | conventional alveolar recruitment |
Primary outcome
modified lung ultrasound score at the end of surgery
Time frame: At the end of surgery
Both lung ultrasound scores can be calculated by adding up the 12 individual pulmonary quadrant scores yielding a score between 0 (no aeration loss) and 36 (complete aeration loss).
8 secondary outcomes
modified lung ultrasound score at post-anesthesia care unit (PACU)
Time frame: intraoperative
incidence of atelectasis diagnosed by ultrasonography
Time frame: intraoperative
arterial blood gas analyses
Time frame: intraoperative
incidence of postoperative complications
Time frame: during the postoperative period until discharge from hospital, an average of 3 days
intraoperative mean arterial pressure
Time frame: intraoperative
intraoperative SpO2
Time frame: intraoperative
intraoperative peak airway pressure
Time frame: intraoperative
Incidence of postoperative shoulder pain at POD #1
Time frame: assessed at postoperative day 1
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 18 Oct 2019.
- 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.
- Background: PubMed 27804117Song IK, Kim EH, Lee JH, Ro S, Kim HS, Kim JT. Effects of an alveolar recruitment manoeuvre guided by lung ultrasound on anaesthesia-induced atelectasis in infants: a randomised, controlled trial. Anaesthesia. 2017 Feb;72(2):214-222. doi: 10.1111/anae.13713. Epub 2016 Nov 2.
- Derived from this study: PubMed 33399385Park SK, Yang H, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-guided versus conventional lung recruitment manoeuvres in laparoscopic gynaecological surgery: A randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(3):275-284. doi: 10.1097/EJA.0000000000001435.
- Individual participant dataSharing planned: No
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.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound-guided alveolar recruitment and conventional alveolar recruitment in people with Pulmonary Atelectasis, run by Seoul National University Hospital at 2 sites in South Korea.
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 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: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
modified lung ultrasound score at the end of surgery (time frame: At the end of surgery). 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 NCT03607240, 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 18 Oct 2019.