Individualized PEEP in Thoracic Surgery

Individualized vs Standard PEEP in Thoracic Surgery: Effects on Respiratory Mechanics and Intra- and Postoperative Oxygenation

Intraoperative protective ventilation with low tidal volumes (TV), positive end-expiratory pressure (PEEP) and possibly lung recruitment maneuvers (RMs) reduces postoperative pulmonary complications. In thoracic surgery, in one-lung ventilation (OLV), the evidence is lacking. However, in this context protective ventilation with PEEP titration is related to better intraoperative oxygenation and respiratory mechanics. It is not clear whether this strategy is associated also with better postoperative oxygenation and less postoperative pulmonary complications.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; One-lung Ventilation; Respiratory Mechanics; Artificial Respiration
• Intervention / Treatment: Procedure: Best PEEP; Procedure: Standard PEEP

Detailed Description

In this randomized controlled trial the investigators will enroll 42 patients scheduled for elective thoracic surgery (minithoracotomic or video-assisted thoracoscopic segmentectomies and lobectomies). Patients will be randomized in two groups: BEST PEEP and STANDARD PEEP. In OLV the investigator will set a TV = 5ml/kg IBW in volume control ventilation (VCV) and an adequate respiratory rate (RR) to keep PaCO2 < 60 mmHg. With the patient in lateral decubitus and open chest, a cycling step RM (in pressure control ventilation, RR =10/min, I:E=1:1, up to Paw = 40 cmH20 with a PEEP = 20 cmH2O, lasting 2.5 minutes) and a PEEP decremental titration trial (in VCV, from 16 to 4 cmH2O) will be performed to all patients. Then, after another RM, in STANDARD PEEP group a PEEP of 5 cmH2O will be set, and in BEST PEEP group an individualized PEEP (the one corresponding to the lower driving pressure, +2 cmH2O) will be applied till the end of surgery. A blood gas analysis will be performed before surgery, with the patient in supine position breathing room air (T1). The respiratory mechanics (Ppeak, Pplateau, PEEP, driving pressure) and blood gas (PaO2, PaCO2, pH, HCO3, lactates) parameters will be then collected at the following time points: T2 - 5 minutes after induction, patient supine, two lung ventilation; T3 - lateral decubitus, chest open, OLV, before RM; T4 - 10 minutes after second RM; T5, 6, 7 - every hour after T4; T8 - at the end of OLV, before lung re-expansion; T9 - patient supine, two lung ventilation, before neuromuscular block reversal. Postoperatively all patients will spend at least one hour in a Recovery Room, in oxygen-therapy through a Venturi mask with FiO2 = 60%. A blood gas analysis and data about pain (NRS scale 0-10) and sedation (Ramsey score) will be collected at 1 hour postoperatively (T10). The primary outcome of the study is intra- and postoperative oxygenation and secondary outcomes are intraoperative respiratory mechanics parameters.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 34149
    • Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patient's consent to the trial
• Candidate to elective lung lobectomy or segmentectomy (minimally invasive thoracotomy or video-assisted thoracoscopy)
• ASA class 1-3
• BMI < 30 kg/m2

Exclusion criteria:

• Pregnancy
• Previous pneumothorax,
• Emphysematous bullae
• Severe COPD
• METs < 4 due to cardiac disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BEST PEEP; During OLV an individualized PEEP will be applied i.e. the one corresponding to the lower driving pressure, + 2 cmH2O	Procedure: Best PEEP; In OLV, the investigator will perform a PEEP decremental titration trial, decreasing PEEP from 16 to 4 cmH2O (steps of 2-cmH2O, lasting 1 minute). At the end of every step driving pressure (Pplat-PEEP) will be calculated, and the PEEP corresponding to the lowest driving pressure + 2cmH2O will be set.
ACTIVE_COMPARATOR: STANDARD PEEP; During OLV a PEEP of 5 cmH2O will be applied	Procedure: Standard PEEP; In OLV, a PEEP of 5 cm H2O will be set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of oxygenation	Oxygen arterial partial pressure/fraction of inspired oxygen (PaO2/FiO2)	The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of driving pressure	Driving pressure = Pplateau -PEEP	The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.
Change of plateau pressure	Airway pressure during an end-inspiratory pause	The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.
Change of static respiratory system compliance	Cstat = TV/(Pplat-PEEP)	The respiratory mechanics parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.
Change of respiratory rate	Respiratory rate set on the ventilator	The parameter will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.
Change of carbon dioxide	Carbon dioxide arterial partial pressure	The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons.
Change of end expiratory carbon dioxide partial pressure	Carbon dioxide end-expiratory partial pressure	The respiratory parameters will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.
Change of pH	Arterial pH	The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons.
Lactate	Arterial lactate	The blood gas analysis will be performed at the time points from T1 to T10 (preoperative, during surgery and 1 hour postoperative). The investigators will perform intra- and inter-group comparisons.

Collaborators and Investigators

• Sponsor: University of Trieste
• Investigators: Principal Investigator: Lucia Comuzzi, Azienda sanitaria universitaria Giuliano Isontina (ASU GI)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2021
• Primary Completion (ACTUAL): December 4, 2021
• Study Completion (ACTUAL): December 5, 2021

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: One-lung ventilation; Oxygenation; Individualized PEEP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 49/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No