Positive End Expiratory PressureNCT05261295
Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position
An observational study of Positive End Expiratory Pressure and Lung Ultrasound, run by Ankara City Hospital Bilkent.
Trial summary
The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Positive End Expiratory Pressure, Lung Ultrasound
- What is being tested?
- PEEP and ZEEP
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jul 2022
- How long will I take part?
- 6 Days
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy
Who may be able to join
- ASA I-III
- Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy
Who cannot join
- Heart failure (ejection fraction < 40%),
- unstable hemodynamic conditions
- Having neck or upper respiratory tract pathology,
- have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),
- obesity (body mass index≥30 kg m-2)
- Patients with poor tooth structure will also be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of PEEP Applying in Terms of Perioperative Oxygenation and Postoperative Pulmonary Complications in the Use of Classical LMA and I-gel in Urological Surgery Procedures in Lithotomy Position
The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.
- Conditions
- Positive End Expiratory Pressure, Lung Ultrasound
- Being tested
- PEEP, ZEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPDiagnostic test
PEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.
ZEEPDiagnostic test
PEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion.
| Study group | Role | What they receive |
|---|---|---|
| Classical LMA | Patients who received general anesthesia with classical LMA Receives: Diagnostic Test: PEEP; Diagnostic Test: ZEEP | |
| i-Gel | Patients who received general anesthesia with i-Gel Receives: Diagnostic Test: PEEP; Diagnostic Test: ZEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS score preop
Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.
Measured: Baseline
LUS score postoperative
Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.
Measured: postoperative 1.hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive End Expiratory PressureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, canan ün, Ankara City Hospital Bilkent
- Investigators
- canan ün, MD, Principal investigator, ankara ch bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261295
- Sponsor's protocol ID
- E1-21-2260
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PEEP Applying in Terms of Perioperative Oxygenation and Postoperative Pulmonary Complications in the Use of Classical LMA and I-gel in Urological Surgery Procedures in Lithotomy Position
- ClinicalTrials.gov ID
- NCT05261295
- Acronym / sponsor ID
- E1-21-2260
- Conditions
- Positive End Expiratory Pressure, Lung Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Mar 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.
The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical LMA | – | Diagnostic Test: PEEP, Diagnostic Test: ZEEPPatients who received general anesthesia with classical LMA |
| i-Gel | – | Diagnostic Test: PEEP, Diagnostic Test: ZEEPPatients who received general anesthesia with i-Gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy
Key inclusion criteria (2 listed)
- ASA I-III
- Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy
Key exclusion criteria (6 listed)
- Heart failure (ejection fraction < 40%),
- unstable hemodynamic conditions
- Having neck or upper respiratory tract pathology,
- have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),
- obesity (body mass index≥30 kg m-2)
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 |
|---|---|---|
| PEEPPEEP of 7 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion. | Diagnostic test | Classical LMA, i-Gel |
| ZEEPPEEP of 0 cmH2O will be applied 5 minutes after classical LMA or i-gel insertion. | Diagnostic test | Classical LMA, i-Gel |
Primary outcome
LUS score preop
Time frame: Baseline
Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.
LUS score postoperative
Time frame: postoperative 1.hour
Loss of ventilation will be evaluated by calculating the LUS score. Each region will be scored according to the LUS model as follows: Presence of lung deviation with lines or less than two isolated B-lines is scored as 0; 1 point in the presence of more than one well-defined B line; presence of more than one combined B line, 2 points; and when a tissue pattern characterized by dynamic air bronchograms (lung consolidation) is presented, the score is 3. The worst ultrasound pattern observed in each region will be recorded and used to calculate the sum of the scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Positive End Expiratory Pressure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Recruiting
Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
Postoperative Pulmonary Complications, Mechanical Ventilation
Not yet recruitingPhase 1/2
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
Congenital Heart Disease, Cardiopulmonary Bypass
RecruitingPhase 1/2
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
Congenital Heart Disease, Cardiopulmonary Bypass
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.
canan ün, MD principal investigator
ankara ch bilkent
Questions about this trial
What is this clinical trial studying?
An observational study of Positive End Expiratory Pressure and Lung Ultrasound, run by Ankara City Hospital Bilkent.
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 6 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmet Demirörs, MD (+905548997181, drahmetdemirors@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUS score preop (time frame: Baseline). 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 2 Mar 2022.