RecruitmentNCT04269226
Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients
A study testing Recruitment maneuver and No recruitment maneuver in people with Recruitment and Obesity, Morbid, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery. 128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recruitment, Obesity, Morbid, Laparoscopy
- What is being tested?
- Recruitment maneuver and No recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2019to 9 May 2020
- 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
- Patients between the ages of 18 and 65
- Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery
- ASA (American Society of Anesthesiologists) 2-3 patients
Who cannot join
- Smokers
- Patients with previous abdominal surgery
- Patients with obstructive / restrictive lung disease,
- Patients with coronary artery disease, heart failure
- Patients with chronic kidney failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul, 34147
Basak Bayrak, MD, +902124147171, basakbayrak2009@gmail.com
About this study
Official title: The Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics and Postoperative Kidney Functions of Obese Patients Undergoing Laparoscopic Abdominal Surgery
This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery.
128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.
- Conditions
- Recruitment, Obesity, Morbid, Laparoscopy
- Being tested
- Recruitment maneuver, No recruitment maneuver
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment maneuverProcedure or surgery
Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal peep for the patient, and PEEP will be adjusted at this value after recruitment.
No recruitment maneuverProcedure or surgery
Usual ventilation procedures will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Recruitment maneuver | Experimental | Recruitment maneuver Receives: Procedure: Recruitment maneuver |
| No recruitment maneuver | Active comparator | No recruitment maneuver Receives: Procedure: No recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Plateau airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Driver airway pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Static airway compliance
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Dynamic airway compliance
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
End tidal CO2 pressure
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Secondary outcomes (5)
Heart rate
This will me measured at 5 different times using electrocardiography and will be reported as beat per minute (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Mean arterial pressure
This will me measured at 5 different times using non invasive blood pressure monitor and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
SpO2
SpO2 will me measured at 5 different times using pulse oximetry and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Measured: 1 week
Creatinine
Creatinine values will be measured at 24th our using blood tests and will be reported as mg/dL
Measured: 24th hour
Urine output
This will be measured hourly for the first 24 hours, using urinary catheter and will be reported as ml per hour.
Measured: 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start9 Apr 2019
- Primary completion9 Apr 2020 (estimated)
- Study completion9 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269226
- Sponsor's protocol ID
- 20190409
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 13 Feb 2020
- 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 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics and Postoperative Kidney Functions of Obese Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04269226
- Acronym / sponsor ID
- 20190409
- Conditions
- Recruitment, Obesity, Morbid, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 9 Apr 2020 (estimated)
- Study completion
- 9 May 2020 (estimated)
- First posted
- 13 Feb 2020 (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.
This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery.
128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment maneuver | Experimental | Procedure: Recruitment maneuverRecruitment maneuver |
| No recruitment maneuver | Active comparator | Procedure: No recruitment maneuverNo recruitment maneuver |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between the ages of 18 and 65
- Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery
- ASA (American Society of Anesthesiologists) 2-3 patients
Key exclusion criteria (5 listed)
- Smokers
- Patients with previous abdominal surgery
- Patients with obstructive / restrictive lung disease,
- Patients with coronary artery disease, heart failure
- Patients with chronic kidney 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 |
|---|---|---|
| Recruitment maneuverFollowing intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal peep for the patient, and PEEP will be adjusted at this value after recruitment. | Procedure or surgery | Recruitment maneuver |
| No recruitment maneuverUsual ventilation procedures will be applied. | Procedure or surgery | No recruitment maneuver |
Primary outcome
Peak airway pressure
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Plateau airway pressure
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Driver airway pressure
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Static airway compliance
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
Dynamic airway compliance
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
End tidal CO2 pressure
Time frame: 1 week
This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)
5 secondary outcomes
Heart rate
Time frame: 1 week
Mean arterial pressure
Time frame: 1 week
SpO2
Time frame: 1 week
Creatinine
Time frame: 24th hour
Urine output
Time frame: 24th hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- 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 and No recruitment maneuver in people with Recruitment and Obesity, Morbid, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 5 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 13 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basak Bayrak, MD (+902124147171, basakbayrak2009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak airway pressure (time frame: 1 week). The study lists 6 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 13 Feb 2020.