NCT04740151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2021

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

January 15, 2021

Last Update Submit

September 25, 2022

Conditions

Thoracic SurgeryOne-lung VentilationRespiratory MechanicsArtificial Respiration

Keywords

Individualized PEEPOne-lung ventilationOxygenation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change of driving pressure

    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

    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

    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

    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

    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.

  • +3 more secondary outcomes

Study Arms (2)

BEST PEEP

EXPERIMENTAL

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

Procedure: Best PEEP

STANDARD PEEP

ACTIVE COMPARATOR

During OLV a PEEP of 5 cmH2O will be applied

Procedure: Standard PEEP

Interventions

Best PEEPPROCEDURE

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.

BEST PEEP
Standard PEEPPROCEDURE

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

STANDARD PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Universitaria Giuliano-Isontina, Cattinara Hospital

Trieste, 34149, Italy

Location

Study Officials

  • Lucia Comuzzi

    Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2021

First Posted

February 5, 2021

Study Start

January 4, 2021

Primary Completion

December 4, 2021

Study Completion

December 5, 2021

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)