Optimization of PEEP During Laparoscopic Surgery
Primary Purpose
Post-Op Complication, Ventilator-Induced Lung Injury
Status
Recruiting
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
Respiratory monitoring
Capnography
Arterial blood gas
Esophageal pressure
Sponsored by
About this trial
This is an interventional prevention trial for Post-Op Complication focused on measuring positive end-expiratory pressure, esophageal pressure, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- patients with calculous cholecystitis American Society of Anesthesiologists Classification (ASA) I-II
Exclusion Criteria:
- pregnancy
- age less than 18 or more than 65 years
- patients ASA III-IV
- 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 tumour metastases in lungs
- chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure)
- Glasgow coma score < 14
- upper airways obstruction
Sites / Locations
- National Research Oncology and Transplantology CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PEEP Pes
PEEP 5
Arm Description
PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group)
PEEP constantly set at 5 cmH2O (control group)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Dynamics of the end-expiratory lung volume
Calculation the end-expiratory lung volume (ml) and compare with expected and between groups
Dynamics of the respiratory biomechanics
Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points
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
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
Dynamics of the hemodynamic parameters
Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points
Full Information
NCT ID
NCT05222893
First Posted
November 24, 2021
Last Updated
July 10, 2023
Sponsor
Karaganda Medical University
Collaborators
I.M. Sechenov First Moscow State Medical University, National Research Oncology and Transplantology Center, Kazakhstan
1. Study Identification
Unique Protocol Identification Number
NCT05222893
Brief Title
Optimization of PEEP During Laparoscopic Surgery
Official Title
Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
March 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karaganda Medical University
Collaborators
I.M. Sechenov First Moscow State Medical University, National Research Oncology and Transplantology Center, Kazakhstan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication, Ventilator-Induced Lung Injury
Keywords
positive end-expiratory pressure, esophageal pressure, laparoscopic surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEEP Pes
Arm Type
Active Comparator
Arm Description
PEEP adjustment according to the pressure indicators in the lower third of the esophagus Pes (intervention group)
Arm Title
PEEP 5
Arm Type
Active Comparator
Arm Description
PEEP constantly set at 5 cmH2O (control group)
Intervention Type
Diagnostic Test
Intervention Name(s)
Respiratory monitoring
Intervention Description
Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation
Intervention Type
Diagnostic Test
Intervention Name(s)
Capnography
Intervention Description
Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute
Intervention Type
Diagnostic Test
Intervention Name(s)
Arterial blood gas
Intervention Description
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
Intervention Type
Device
Intervention Name(s)
Esophageal pressure
Intervention Description
Measurement the pressure in the lower third of esophagus during inspiration and expiration
Primary Outcome Measure Information:
Title
Change in arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio
Description
Calculation of the arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio using arterial oxygen tension measurement and compare between groups
Time Frame
5 minutes before intubation,1 hour after surgery, 24 hour after surgery
Secondary Outcome Measure Information:
Title
Dynamics of the end-expiratory lung volume
Description
Calculation the end-expiratory lung volume (ml) and compare with expected and between groups
Time Frame
5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Title
Dynamics of the respiratory biomechanics
Description
Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points
Time Frame
5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Title
Dynamics of the volume of CO2 eliminated per minute
Description
Measurement of volume of CO2 eliminated per minute (VCO2 in ml/min), than compare the trends as a marker of lung ventilation
Time Frame
5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Title
Dynamics of the partial pressure of CO2 in exhaled gas
Description
Measurement of partial pressure of CO2 in exhaled gas (PetCO2 in mmHg) than compare the trends as a marker of lung ventilation
Time Frame
5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Title
Dynamics of the hemodynamic parameters
Description
Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points
Time Frame
5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing laparoscopic surgery with mechanical lung ventilation American Society of Anesthesiologists Classification (ASA) I-III
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gulfairus A Yessenbayeva, MD, PhDc
Phone
+77788434563
Email
yessenbay_gufa@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Andrey I Yaroshetskiy, MD, PhD, ScD
Phone
+79859900148
Email
dr.intensivist@gmail.com
Facility Information:
Facility Name
National Research Oncology and Transplantology Centre
City
Astana
State/Province
Select
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gulfairus Yessenbayeva
Phone
87788434563
Email
yessenbay.gufa@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24919591
Citation
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;(6):CD007922. doi: 10.1002/14651858.CD007922.pub3.
Results Reference
background
PubMed Identifier
26332856
Citation
Bender 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.
Results Reference
background
PubMed Identifier
30277931
Citation
Kacmarek 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.
Results Reference
background
PubMed Identifier
19001507
Citation
Talmor 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.
Results Reference
background
PubMed Identifier
25549487
Citation
Iaroshetskii 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.
Results Reference
background
PubMed Identifier
30260897
Citation
Pereira 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.
Results Reference
background
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Optimization of PEEP During Laparoscopic Surgery
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