Optimization of PEEP During Laparoscopic Surgery

Ventilator-Induced Lung Injury Clinical Trial

Official title:

Optimization of Positive End-expiratory Pressure During Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222893
• Other study ID #: PEEP-TPP
• Status: Completed
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: March 26, 2024

Study information

• Verified date: April 2024
• Source: Karaganda Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 26, 2024
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Injury
• Post-Op Complication
• Postoperative Complications
• Ventilator-Induced Lung Injury

Intervention

Diagnostic Test:
• Respiratory monitoring
Measurement of the plateau pressure, positive end-expiratory pressure, driving pressure, end-expiratory lung volume, compliance of respiratory system on volume-controlled ventilation
• Capnography
Measurement of end-tidal carbon dioxide tension, volume of CO2 eliminated per minute
• Arterial blood gas
Measurement of the oxygen partial pressure and the carbon dioxide partial pressure

Device:
• Esophageal pressure
Measurement the pressure in the lower third of esophagus during inspiration and expiration

Locations

Country	Name	City	State
Kazakhstan	National Research Oncology and Transplantology Centre	Astana	Select

Sponsors (3)

Lead Sponsor	Collaborator
Karaganda Medical University	I.M. Sechenov First Moscow State Medical University, National Research Oncology and Transplantology Center, Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 minutes before intubation,1 hour after surgery, 24 hour after surgery
Secondary	Dynamics of the end-expiratory lung volume	Calculation the end-expiratory lung volume (ml) and compare with expected and between groups	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Secondary	Dynamics of the respiratory biomechanics	Calculation the compliance of respiratory system (ml/mbar) and compare between groups at all time points	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Secondary	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	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Secondary	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	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position
Secondary	Dynamics of the hemodynamic parameters	Measurement of the arterial blood pressure (mmHg) and compare between groups at all time points	5 minutes after induction and intubation, 5 minutes after PEEP setting, 5 minutes after pneumoperitoneum, 5 minutes after reverse Trendelenburg position