Know Cancer

or
forgot password

Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation


N/A
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Pulmonary Disease

Thank you

Trial Information

Lowering VT and Increasing PEP During One-Lung Ventilation (OLV), Impact on Oxygenation


Approval Status: Approved Approval Number: 2007-06 Board Name: CPP Sud Ouest et
Outre-Mer 3 Board Affiliation: French Ministry of Health (DGS) Phone: Email:
cpp.soom3@orange.fr No France: Afssaps - French Health Products Safety Agency

During general anesthesia, airway closure and the formation of atelectasis impair
oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis
with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The
reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar
derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the
impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar
recruitment when TV is reduced.

A recent study reported that mechanical ventilation with large intraoperative TV is
associated with an increased risk of post-pneumonectomy respiratory failure. Indeed, large
TV during OLV may lead to Ventilator-Induced Lung Injury (VILI) with the creation of
alveolar stretch injury and the development of permeability pulmonary edema. The reduction
in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment.
This harmful effect may be counteracted by PEP. Therefore, once TV is reduced, PEP may play
a key role in minimizing lung collapse and preventing lung units from repeated opening and
collapse phases. Such "protective" ventilatory strategy may be proposed if it does not lead
to hypoxemia during exclusion. We, therefore, study the impact on oxygenation, of increasing
PEP in order to maintain recruitment, keeping Pplat constant when TV is reduced. We will
compare, in each patient without severe pulmonary obstructive disease (FEV1 and FEV1 /CV >
70%), two strategies of ventilation with two different levels of TV and PEP, but keeping the
same Pplat :

After induction of anesthesia, fiberoptic bronchoscopy confirms the correct position of the
tube. Anesthesia is maintained with sevoflurane with a BIS® objective between 45 and 55.
Boluses of sufentanyl and cisatracurium are done when clinically necessary. Patients are
ventilated in VCV with a ZEUS® respiratory device (Dragger, Germany). Before incision,
patients are switched to one-lung ventilation in the lateral position. The tidal volume (TV)
is 8 ml/kg of ideal body weight, with a maximal plateau pressure limited to 32 cm H2O. The
ventilatory frequency is adjusted in order to maintain end tidal concentrations of carbon
dioxide (PetCO2) between 30 to 35 mmHg. 5 cmH2O of positive end expiratory pressure (PEP) is
used, and the inspired oxygen fraction is adjusted in order to maintain the pulse oxymetry
above 95%. During OLV, if SpO2 decreases to less than 90% with 100% of inspired oxygen
fraction, surgery is temporarily stopped to resume two lungs ventilation until SpO2 recover
at least 95%. If necessary, a continuous positive airway pressure (CPAP) with 5 cm H2O of
oxygen is maintained to provide the non dependent lung. Datas are recorded when the chest is
opened. The alveolar pressures and the inspiratory and expiratory flow time curves are
monitored. After a period of 15 min, the two strategies are compared in a random order :

- TV of 8 ml/kg of ideal body weight and a PEP of 5 cmH2O during 10 minutes

- TV of 5 ml/kg and a PEP level in order to keep the same plateau pressure during 10
minutes.

Arterial blood gases are measured after 10 minutes using each strategy and before any
vessels are ligated. The occurrence of PEPi is detected on the expiratory flow time curve.


Inclusion Criteria:



- Age> 18 years

- Open-chest thoracotomy for pulmonary resection

- oral consent

Exclusion Criteria:

- Severe obstructive disease (FEV1 or FEV1 /CV < 70%)

- Patient who don't tolerate a one-lung ventilation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

PaO2/FiO2 after 10 minutes of each strategy

Outcome Time Frame:

15 minutes after selective intubation and 10 minutes after the beginning of each ventilation type.

Safety Issue:

No

Principal Investigator

Hadrien ROZE, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CHUBX 2007/06

NCT ID:

NCT00534690

Start Date:

November 2007

Completion Date:

January 2009

Related Keywords:

  • Lung Neoplasms
  • Pulmonary Disease
  • Pulmonary disease
  • Intubation, Intratracheal
  • Positive-pressure ventilation
  • Neoplasms
  • Lung Diseases
  • Respiration Disorders
  • Lung Neoplasms

Name

Location