Skip to main content
OpenTrials
Completed

NCT Number: NCT04740151

Individualized PEEP in Thoracic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic Surgery Artificial Respiration One-Lung Ventilation Respiratory Mechanics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital

Trieste, 34149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best PEEP

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

Procedure

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

Primary outcomes

  1. Change of oxygenation

    Time frame: 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.

    Oxygen arterial partial pressure/fraction of inspired oxygen (PaO2/FiO2)

Secondary outcomes

  1. Change of driving pressure

    Time frame: 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.

    Driving pressure = Pplateau -PEEP

  2. Change of plateau pressure

    Time frame: 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.

    Airway pressure during an end-inspiratory pause

  3. Change of static respiratory system compliance

    Time frame: 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.

    Cstat = TV/(Pplat-PEEP)

  4. Change of respiratory rate

    Time frame: The parameter will be collected at the time points from T2 to T9 (during surgery). The investigators will perform intra- and inter-group comparisons.

    Respiratory rate set on the ventilator

  5. Change of carbon dioxide

    Time frame: 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.

    Carbon dioxide arterial partial pressure

  6. Change of end expiratory carbon dioxide partial pressure

    Time frame: 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.

    Carbon dioxide end-expiratory partial pressure

  7. Change of pH

    Time frame: 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.

    Arterial pH

  8. Lactate

    Time frame: 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.

    Arterial lactate

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.