Gynecologic Surgical ProceduresNCT05713929
Study of Atelectasis by Electrical Impedance Tomography
A study testing Recruitment maneuver (RM) and Reverse Trend (REV TREND) in people with Gynecologic Surgical Procedures and Urologic Surgical Procedures, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gynecologic Surgical Procedures, Urologic Surgical Procedures
- What is being tested?
- Recruitment maneuver (RM) and Reverse Trend (REV TREND)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Feb 2023to 31 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects over eighteen years old;
- Requiring laparoscopic gynecological, urological or digestive surgery;
- Surgery requiring Trendelenburg position and tracheal intubation.
Who cannot join
- Emergency operation;
- Thoracic surgery;
- Pulmonary, cardiac pathology;
- Pregnant woman;
- BMI > 30;
- Comorbidities defined as an American Society of Anesthesiologists physical condition greater than 2;
- Language barrier;
- Refusal of consent.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
HUB Hôpital Erasme
Brussels, Anderlecht, 1070
Thibaut Decoeur, PG, +32478767308, t.decoeur@hotmail.com
Laszlo Szegedi, M.D, PhD, +3225555546, Laszlo.Szegedi@erasme.ulb.ac.be
About this study
Official title: Study of Atelectasis by Electrical Impedance Tomography and the Effects of Different Positions on Their Occurrence, Reversibility and Regional Distribution, During General Anesthesia
The goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation.
The main questions it aims to answer are:
Read more
- The increase in atelectasis after induction of general anesthesia in supine and Trendelenburg position compared with baseline (spontaneous breathing)
- The eventual possibility of reversal of atelectasis caused by general anesthesia and Trendelenburg position by reverse Trendelenburg position and recruitment manœuvre.
Participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended Trendelenburg position.
- Being tested
- Recruitment maneuver (RM), Reverse Trend (REV TREND)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuver (RM)Other
performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance
Reverse Trend (REV TREND)Other
Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver (RM) group 1 | Active comparator | Not described Receives: Other: Recruitment maneuver (RM) |
| Reverse Trend (REV TREND) group 2 | Active comparator | Not described Receives: Other: Reverse Trend (REV TREND) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of atelectasis after induction of general anesthesia (Time 1)
percentage
Measured: from the base measure to time 1 (10 minutes)
the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)
percentage
Measured: from the base measure to time 2 (15 minutes)
Secondary outcomes (1)
The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)
percentage
Measured: from the base measure to time 3 (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start6 Feb 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Surgical ProceduresStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. 1st measurement (T0-SPONT): in spontaneous ventilation. 2. Induction, intubation and mechanical ventilation for 5 minutes. 3. 2nd measurement (T1-LYING): after induction. 4. Trendelenburg 30° and ventilatory constant parameters. 5. 3rd measurement (T2-TREND): after 5 minutes of Trendelenburg. 6. Division into 2 groups according to randomization: I. Supine position and recruitment manoeuvre. 4th measurement after 5 minutes. (T3-RM) II. Either put in the Anti Trendelenburg position. 4th measurement after 5 minutes. (TREND Q3- REV) 7. Horizontal supine position and surgical incision.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713929
- Sponsor's protocol ID
- B4062022000256
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Atelectasis by Electrical Impedance Tomography and the Effects of Different Positions on Their Occurrence, Reversibility and Regional Distribution, During General Anesthesia
- ClinicalTrials.gov ID
- NCT05713929
- Acronym / sponsor ID
- B4062022000256
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 6 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 goal of this interventional study is to learn about the effects of different positions on the occurrence, regional distribution and reversibility of atelectasis by using a PulmoVista 500 monitor (Dräger. 23542 Lübeck), during general anesthesia with mechanical ventilation.
The main questions it aims to answer are:
- The increase in atelectasis after induction of general anesthesia in supine and Trendelenburg position compared with baseline (spontaneous breathing)
- The eventual possibility of reversal of atelectasis caused by general anesthesia and Trendelenburg position by reverse Trendelenburg position and recruitment manœuvre.
Participants will be adult, autonomous and able to express their will, undergoing elective gynecological or urological surgery in the extended Trendelenburg position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. 1st measurement (T0-SPONT): in spontaneous ventilation. 2. Induction, intubation and mechanical ventilation for 5 minutes. 3. 2nd measurement (T1-LYING): after induction. 4. Trendelenburg 30° and ventilatory constant parameters. 5. 3rd measurement (T2-TREND): after 5 minutes of Trendelenburg. 6. Division into 2 groups according to randomization: I. Supine position and recruitment manoeuvre. 4th measurement after 5 minutes. (T3-RM) II. Either put in the Anti Trendelenburg position. 4th measurement after 5 minutes. (TREND Q3- REV) 7. Horizontal supine position and surgical incision.
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver (RM) group 1 | Active comparator | Other: Recruitment maneuver (RM) |
| Reverse Trend (REV TREND) group 2 | Active comparator | Other: Reverse Trend (REV TREND) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects over eighteen years old;
- Requiring laparoscopic gynecological, urological or digestive surgery;
- Surgery requiring Trendelenburg position and tracheal intubation.
Key exclusion criteria (8 listed)
- Emergency operation;
- Thoracic surgery;
- Pulmonary, cardiac pathology;
- Pregnant woman;
- BMI > 30;
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 maneuver (RM)performance of a recruitment maneuver of 30 cm H20 for 30 seconds and measurement of electrical impedance | Other | Recruitment maneuver (RM) group 1 |
| Reverse Trend (REV TREND)Place the patient in the reverse trendelenburg position and measuring the electrical impedance after 5 minutes | Other | Reverse Trend (REV TREND) group 2 |
Primary outcome
the percentage of atelectasis after induction of general anesthesia (Time 1)
Time frame: from the base measure to time 1 (10 minutes)
percentage
the percentage of atelectasis after being positioned in the trendelenburg position (Time 2)
Time frame: from the base measure to time 2 (15 minutes)
percentage
1 secondary outcome
The eventual possibility of reversal of atelectasis by reverse Trendelenburg position and recruitment maneuver (Time 3)
Time frame: from the base measure to time 3 (20 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Lung RecruitmentLink provided by the sponsor.
- Mechanisms of atelectasis in the perioperative periodLink provided by the sponsor.
- Impedance tomography as a new monitoring techniqueLink provided by the sponsor.
- Effect of Positive End Expiratory Pressure on regional ventilation during laparoscopic surgery monitored by electrical impedance tomographyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 (RM) and Reverse Trend (REV TREND) in people with Gynecologic Surgical Procedures and Urologic Surgical Procedures, run by Erasme University Hospital at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 15 Mar 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of atelectasis after induction of general anesthesia (Time 1) (time frame: from the base measure to time 1 (10 minutes)). The study lists 2 primary outcomes in all. 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 15 Mar 2023.