Post-Op ComplicationNCT05222893
Optimization of PEEP During Laparoscopic Surgery
A study testing Respiratory monitoring, Capnography and Arterial blood gas in people with Post-Op Complication and Ventilator-Induced Lung Injury, run by Karaganda Medical University at 1 site in Kazakhstan.
Trial summary
Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Op Complication, Ventilator-Induced Lung Injury
- What is being tested?
- Respiratory monitoring, Capnography and Arterial blood gas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- 14 Apr 2021to 26 Mar 2024
- 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
- Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III
Who cannot join
- pregnancy
- age less than 18 or more than 70 years
- patients ASA > III
- life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg despite norepinephrine at a dose > 2 μg/kg/min
- primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumor metastases in the lungs
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumor progression, liver cirrhosis, congestive heart failure)
- Glasgow coma score < 14
- upper airways obstruction
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
National Research Oncology and Transplantology Centre
Astana, Select, 010000
About this study
Official title: Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery
Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Data on the positive end-expiratory pressure (PEEP) parameters adjustment in laparoscopic surgery, as well as the effects on the respiratory biomechanics, lung tissue and respiratory muscles damage are limited and not clear.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
Read the detailed description
During laparoscopic surgery pressure on alveoli increases, due to in the conditions of pneumoperitoneum, muscle relaxation, the patient's position on the operating table, excess body weight and other factors. As the consequence, the alveoli collapse due to negative transpulmonary pressure. The personalized PEEP adjustment for each particular patient during laparoscopic surgery can help to avoid the adverse effects on biomechanical parameters of the respiratory system, the early PPC incidence and improve overall patients' recovery.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
Investigators will measure if PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) versus PEEP constantly set at 5 cmH2O (control group) gives better outcomes and prevent the early PPC incidence in hospitals.
After the induction, intubation and insertion of the esophageal balloon catheter, TV for patients both groups is set to 6 ml / kg BMI: for men (50+0.91* (height-152.4), for women (45+0.91* (height-152.4); minute ventilation (MV) to ensure the level of PetCO2 - 30-35 mmHg, respiratory rate (RR) 15-25/min (maximum up to 35/min).
Gas exchange parameters including partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood will be measured before the induction (T0), after 1 hour after surgery (T5) and after 24 hours after surgery (T6), then will calculate PAO2/FiO2 respectively.
FiO2, oxygen saturation (SpO2), hemodynamic parameters including blood pressure (BP), heart rate (HR) will be recorded in all point of the study.
Following respiratory mechanics will be measured: plateau pressure (Pplat), PEEP, driving pressure (DP), Pes during inspiration and expiration, volumetric capnometry (VCO2), end-tidal carbon dioxide tension (PetCO2).
Respiratory system compliance (Cstat, Cl, Ccw), end-expiratory lung volume (EELV) will calculated after intubation (T1), after PEEP set according to the patient's group allocation PEEP Pes and PEEP 5 (T2), after initiating pneumoperitoneum (T3) and placing the patient in the reverse Trendelenburg position (T4).
This is a randomized controlled study in the operating room of the University hospitals.
- Being tested
- Respiratory monitoring, Capnography, Arterial blood gas, Esophageal pressure
- Keywords
- positive end-expiratory pressure, esophageal pressure, laparoscopic surgery
- Medical subject headings
- Postoperative Complications, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory monitoringDiagnostic test
Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation
CapnographyDiagnostic test
Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute
Arterial blood gasDiagnostic test
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
Esophageal pressureDevice
Measurement the pressure in the lower third of esophagus during inspiration and expiration
| Study group | Role | What they receive |
|---|---|---|
| PEEP Pes | Active comparator | PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) Receives: Diagnostic Test: Respiratory monitoring; Diagnostic Test: Capnography; Diagnostic Test: Arterial blood gas; Device: Esophageal pressure |
| PEEP 5 | Active comparator | PEEP constantly set at 5 cmH2O (control group) Receives: Diagnostic Test: Respiratory monitoring; Diagnostic Test: Capnography; Diagnostic Test: Arterial blood gas; Device: Esophageal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups
Measured: 5 minutes before intubation,1 hour after surgery, 24 hour after surgery
Secondary outcomes (5)
Dynamics of the end-expiratory lung volume
Calculation the end-expiratory lung volume (ml) and compare with expected and between groups
Measured: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the respiratory biomechanics
Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points
Measured: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the volume of CO2 eliminated per minute
Measurement of volume of CO2 eliminated per minute (VCO2 in ml/min), than compare the trends as a marker of lung ventilation
Measured: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the partial pressure of CO2 in exhaled gas
Measurement of partial pressure of CO2 in exhaled gas (PetCO2 in mmHg) than compare the trends as a marker of lung ventilation
Measured: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the hemodynamic parameters
Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points
Measured: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start14 Apr 2021
- Primary completion29 Dec 2023
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaganda Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, National Research Oncology and Transplantology Center, Kazakhstan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222893
- Sponsor's protocol ID
- PEEP-TPP
- Status last verified
- Apr 2024
- First submitted
- 24 Nov 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.
PubMed 24919591Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
PubMed 26332856Kacmarek RM, Villar J. Lung-protective Ventilation in the Operating Room: Individualized Positive End-expiratory Pressure Is Needed! Anesthesiology. 2018 Dec;129(6):1057-1059. doi: 10.1097/ALN.0000000000002476. No abstract available.
PubMed 30277931Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Iaroshetskii AI, Protsenko DN, Rezepov NA, Gel'fand BR. [Positive end-expiratory pressure adjustment in parenchimal respiratory failure: static pressure-volume loop or transpulmonary pressure?]. Anesteziol Reanimatol. 2014 Jul-Aug;59(4):53-9. Russian.
PubMed 25549487Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
PubMed 30260897
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT05222893
- Acronym / sponsor ID
- PEEP-TPP
- Keywords
- positive end-expiratory pressure, esophageal pressure, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karaganda Medical UniversityUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, National Research Oncology and Transplantology Center, Kazakhstan
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 3 Feb 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.
Lung-protective ventilation (LPV) during general anesthesia can trigger the development of early postoperative pulmonary complication (PPC) and ventilator associated lung injury. One of the proven components of the LPV is low tidal volume (TV). Data on the positive end-expiratory pressure (PEEP) parameters adjustment in laparoscopic surgery, as well as the effects on the respiratory biomechanics, lung tissue and respiratory muscles damage are limited and not clear.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
Detailed description
During laparoscopic surgery pressure on alveoli increases, due to in the conditions of pneumoperitoneum, muscle relaxation, the patient's position on the operating table, excess body weight and other factors. As the consequence, the alveoli collapse due to negative transpulmonary pressure. The personalized PEEP adjustment for each particular patient during laparoscopic surgery can help to avoid the adverse effects on biomechanical parameters of the respiratory system, the early PPC incidence and improve overall patients' recovery.
The objective of the study is to evaluate the ability of the esophageal pressure (Pes) based controlled personalized PEEP adjustment, to improve the biomechanics of the respiratory system and oxygenation due to laparoscopic cholecystectomy.
Investigators will measure if PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) versus PEEP constantly set at 5 cmH2O (control group) gives better outcomes and prevent the early PPC incidence in hospitals.
After the induction, intubation and insertion of the esophageal balloon catheter, TV for patients both groups is set to 6 ml / kg BMI: for men (50+0.91* (height-152.4), for women (45+0.91* (height-152.4); minute ventilation (MV) to ensure the level of PetCO2 - 30-35 mmHg, respiratory rate (RR) 15-25/min (maximum up to 35/min).
Gas exchange parameters including partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood will be measured before the induction (T0), after 1 hour after surgery (T5) and after 24 hours after surgery (T6), then will calculate PAO2/FiO2 respectively.
FiO2, oxygen saturation (SpO2), hemodynamic parameters including blood pressure (BP), heart rate (HR) will be recorded in all point of the study.
Following respiratory mechanics will be measured: plateau pressure (Pplat), PEEP, driving pressure (DP), Pes during inspiration and expiration, volumetric capnometry (VCO2), end-tidal carbon dioxide tension (PetCO2).
Respiratory system compliance (Cstat, Cl, Ccw), end-expiratory lung volume (EELV) will calculated after intubation (T1), after PEEP set according to the patient's group allocation PEEP Pes and PEEP 5 (T2), after initiating pneumoperitoneum (T3) and placing the patient in the reverse Trendelenburg position (T4).
This is a randomized controlled study in the operating room of the University hospitals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP Pes | Active comparator | Diagnostic Test: Respiratory monitoring, Diagnostic Test: Capnography, Diagnostic Test: Arterial blood gas, Device: Esophageal pressurePEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group) |
| PEEP 5 | Active comparator | Diagnostic Test: Respiratory monitoring, Diagnostic Test: Capnography, Diagnostic Test: Arterial blood gas, Device: Esophageal pressurePEEP constantly set at 5 cmH2O (control group) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III
Key exclusion criteria (8 listed)
- pregnancy
- age less than 18 or more than 70 years
- patients ASA > III
- life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg despite norepinephrine at a dose > 2 μg/kg/min
- primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumor metastases in the lungs
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 |
|---|---|---|
| Respiratory monitoringMeasurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation | Diagnostic test | PEEP 5, PEEP Pes |
| CapnographyMeasurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute | Diagnostic test | PEEP 5, PEEP Pes |
| Arterial blood gasMeasurement of the oxygen partial pressure and the carbon dioxide partial pressure | Diagnostic test | PEEP 5, PEEP Pes |
| Esophageal pressureMeasurement the pressure in the lower third of esophagus during inspiration and expiration | Device | PEEP 5, PEEP Pes |
Primary outcome
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Time frame: 5 minutes before intubation,1 hour after surgery, 24 hour after surgery
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups
5 secondary outcomes
Dynamics of the end-expiratory lung volume
Time frame: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the respiratory biomechanics
Time frame: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the volume of CO2 eliminated per minute
Time frame: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the partial pressure of CO2 in exhaled gas
Time frame: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Dynamics of the hemodynamic parameters
Time frame: 5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
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 12 Apr 2024.
- Background: PubMed 24919591Barbosa FT, Castro AA, de Sousa-Rodrigues CF. Positive end-expiratory pressure (PEEP) during anaesthesia for prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2014 Jun 12;2014(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.
- Background: PubMed 26332856Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
- Background: PubMed 30277931Kacmarek RM, Villar J. Lung-protective Ventilation in the Operating Room: Individualized Positive End-expiratory Pressure Is Needed! Anesthesiology. 2018 Dec;129(6):1057-1059. doi: 10.1097/ALN.0000000000002476. No abstract available.
- Background: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Background: PubMed 25549487Iaroshetskii AI, Protsenko DN, Rezepov NA, Gel'fand BR. [Positive end-expiratory pressure adjustment in parenchimal respiratory failure: static pressure-volume loop or transpulmonary pressure?]. Anesteziol Reanimatol. 2014 Jul-Aug;59(4):53-9. Russian.
- Background: PubMed 30260897Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
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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.
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 Respiratory monitoring, Capnography and Arterial blood gas in people with Post-Op Complication and Ventilator-Induced Lung Injury, run by Karaganda Medical University at 1 site in Kazakhstan.
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 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 12 Apr 2024. 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 Kazakhstan. 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?
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio (time frame: 5 minutes before intubation,1 hour after surgery, 24 hour after 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 NCT05222893, which also lists 6 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 12 Apr 2024.