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CompletedNCT03435523Updated Feb 19, 2018

The Open Lung Approach During One Lung Ventilation in Thoracic Surgery

An interventional study of Recruitment maneuver in Hypoxemia, sponsored by University of Foggia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by University of Foggia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

  • Question: Ventilatory strategy to counterbalance the effect of one lung ventilation during thoracic surgery.
  • Findings: the open lung approach improved oxygenation and lung compliance, reducing respiratory system driving pressure and transpulmonary driving pressure.
  • Meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of an open lung approach strategy to avoid ventilator lung injury.
Read the detailed description

Background: During thoracic surgery in lateral decubitus, one lung ventilation (OLV) may impair respiratory mechanics and gas exchange. The investigators tested a strategy based on an open lung approach (OLA) consisting in lung recruitment immediately followed by a decremental positive-end expiratory pressure (PEEP) titration to the best respiratory system compliance (CRS) and separately quantified the elastic properties of the lung and the chest wall. The investigators hypothesis was that this approach would improve gas exchange and increase lung compliance (CL).

Methods: In thirteen patients undergoing upper left lobectomy the investigators studied lung and chest wall mechanics, transpulmonary pressure (PL), respiratory system and transpulmonary driving pressure (ΔPRS and ΔPL), gas exchange and hemodynamics at two time-points (a) during OLV at zero end-expiratory pressure (OLVpre-OLA) and (b) after the application of the open-lung strategy (OLVpost-OLA).

02

Conditions studied

  • Hypoxemia

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age > 18 years,
  • surgery and OLV lasting ≥ 60 min

Exclusion criteria

Exclusion Criteria:

  • lung reduction surgery, pneumonectomy, patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) \<60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Open lung approach

    Recruitment maneuver during OLV in thoracic surgery

    Procedure: Recruitment maneuver

Interventions

  • ProcedureRecruitment maneuver

    the ventilator was switched to pressure-control ventilation with a driving pressure of 20 cmH2O. After a 3 min equilibration, PEEP was applied in steps of 5,10,15 and 20 cmH2O every five respiratory breaths; subsequently, after setting a driving pressure of 15 cmH2O, PEEP was stepwise reduced, starting from 15 cmH2O, by 2 cmH2O every 2 minutes. The recruiting pressure of 20/20 was applied for six breaths. During the decremental PEEP trial, CRS was measured at every step. The PEEP level corresponding to highest CRS during the decremental trial was identified as the "best PEEP". Subsequently, the lungs were recruited again and the "best" PEEP was applied.

05

What researchers measure

Primary outcomes

  1. Change in respiratory mechanics before and after the open lung approach

    Respiratory mechanics parameters were recorded, digitized and collected on a personal computer through a 12-bit analog-to digital converter board (DAQCard 700; National Instrument, Austin, TX) at a sample rate of 200 Hz (ICU Lab, KleisTEK Engineering, Bari, Italy).

    Time frame: During surgery

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Rauseo M, Mirabella L, Grasso S, Cotoia A, Spadaro S, D'Antini D, Valentino F, Tullo L, Loizzi D, Sollitto F, Cinnella G. Peep titration based on the open lung approach during one lung ventilation in thoracic surgery: a physiological study. BMC Anesthesiol. 2018 Oct 31;18(1):156. doi: 10.1186/s12871-018-0624-3. PubMed 30382819 ↗
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Registry details

Key details

Study ID
NCT03435523
Lead sponsor
University of Foggia
Responsible party
Gilda Cinnella (Associate Professor, University of Foggia) — Principal investigator
First posted
Feb 19, 2018
Start date
Feb 1, 2012
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012
Last update
Feb 19, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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