Individualized PEEP in Thoracic Surgery

NCT ID: NCT04740151

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2021-12-05

Brief Summary

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.

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.

Conditions

Thoracic Surgery; One-lung Ventilation; Respiratory Mechanics; Artificial Respiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BEST PEEP

During OLV an individualized PEEP will be applied i.e. the one corresponding to the lower driving pressure, + 2 cmH2O

Group Type: EXPERIMENTAL

Best PEEP

Intervention Type: PROCEDURE

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.

STANDARD PEEP

During OLV a PEEP of 5 cmH2O will be applied

Group Type: ACTIVE_COMPARATOR

Standard PEEP

Intervention Type: PROCEDURE

In OLV, a PEEP of 5 cm H2O will be set.

Interventions

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.

Intervention Type: PROCEDURE

Standard PEEP

In OLV, a PEEP of 5 cm H2O will be set.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Trieste

OTHER

Sponsor Role: lead

Responsible Party

Lucia Comuzzi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucia Comuzzi

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Locations

Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital

Trieste, , Italy

Countries

Italy

Other Identifiers

49/2017

Identifier Type: -

Identifier Source: org_study_id