Individualized PEEP in Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04740151
• Other study ID #: 49/2017
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: December 5, 2021

Study information

• Verified date: September 2022
• Source: University of Trieste
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 5, 2021
• Est. primary completion date: December 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Artificial Respiration
• One-lung Ventilation
• Respiratory Mechanics
• Thoracic Surgery

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.