Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-10-30

Brief Summary

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The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery

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Detailed Description

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Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PEEP group

In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached)

Group Type EXPERIMENTAL

incremental PEEP

Intervention Type PROCEDURE

In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached

RM+PEEP group

Recruitment maneuvers will be performed as follow Recruitment maneuvers

1. set FIO2 at 1.0
2. Ppeak limit at 45 cmH2O
3. Respiratory rate set at 6
4. I:E set at 1:1
5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
6. If the maximum VT is set without rasing the Pplat, raise PEEP
7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
8. End of RM

The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).

Group Type EXPERIMENTAL

Recruitment manoeuvers

Intervention Type PROCEDURE

Recruitment manoeuvers will be performed as follow Recruitment manoeuvers

1. set FIO2 at 1.0
2. Ppeak limit at 45 cmH2O
3. Respiratory rate set at 6
4. I:E set at 1:1
5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
6. If the maximum VT is set without rasing the Pplat, raise PEEP
7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
8. End of RM

The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).

Interventions

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Recruitment manoeuvers

Recruitment manoeuvers will be performed as follow Recruitment manoeuvers

1. set FIO2 at 1.0
2. Ppeak limit at 45 cmH2O
3. Respiratory rate set at 6
4. I:E set at 1:1
5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
6. If the maximum VT is set without rasing the Pplat, raise PEEP
7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
8. End of RM

The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).

Intervention Type PROCEDURE

incremental PEEP

In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• Patients undergoing VATS with OLV ≥2 hours

Exclusion Criteria

* ASA (American Society of Anesthesiologists Physical Status Classiﬁcation) score ≥ 4
* severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
* preoperative hemoglobin less than 10 g ml-1
* hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No