UMIN-ICDS Clinical Trial

Public title

Study on the Relationship Between Ventilator Settings During One-Lung Ventilation and Postoperative Pulmonary Complications

Acronym

DRIVE-OLV Study

Scientific Title

Association Between Intraoperative One-Lung Ventilation Parameters and Postoperative Pulmonary Complications: A Prospective Observational Study

Scientific Title:Acronym

DRIVE-OLV Study

Region

Japan

Condition

Adult patients undergoing thoracic surgery requiring one-lung ventilation (OLV)

Classification by specialty

Chest surgery	Anesthesiology	Operative medicine
Emergency medicine	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to prospectively evaluate the impact of intraoperative ventilator parameters, particularly driving pressure, during one-lung ventilation (OLV) in thoracic surgery on postoperative pulmonary complications (PPCs), and to determine the incidence and associated risk factors of PPCs.

Postoperative pulmonary complications frequently occur after surgery, with an incidence reported to be as high as 31.4% in patients undergoing thoracic surgery requiring OLV. PPCs have a substantial impact on patient outcomes and are associated with increased postoperative morbidity, prolonged hospital stay, and higher mortality. However, optimal ventilatory management during OLV, particularly with respect to driving pressure, has not been established. Previous studies have demonstrated an association between driving pressure and PPCs in general surgical populations and in patients with acute respiratory distress syndrome (ARDS); however, evidence specific to OLV remains limited, and retrospective studies have not demonstrated a significant association between driving pressure and PPCs.

Through this study, we aim to clarify the relationship between ventilator parameters during OLV and postoperative pulmonary complications, thereby providing insights that may inform optimal ventilatory strategies in clinical practice.

Basic objectives2

Others

Basic objectives -Others

An observational study to evaluate the association between ventilator parameters during one-lung ventilation and postoperative pulmonary complications

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Association between driving pressure during one-lung ventilation and the postoperative pulmonary complication (PPC) score (Grade 0 to 5), assessed from the end of surgery to hospital discharge.

Key secondary outcomes

1. Identification of ventilator parameters associated with postoperative pulmonary complications defined as PPC score more than 1:

(1) Driving pressure during one lung ventilation
(2) Tidal volume normalized to body weight during one lung ventilation
(3) PaO2/FiO2 ratio during one-lung ventilation
(4) Dead space fraction during one lung ventilation
(5) Respiratory rate during one-lung ventilation
(6) Positive end-expiratory pressure (PEEP) during one-lung ventilation

2. Identification of factors associated with postoperative pulmonary complications defined as PPC score more than 2

3. Determination of a potential safety threshold for driving pressure, if an association is observed, defined as the value at which the adjusted odds ratio for major postoperative pulmonary complications exceeds 1

4. Evaluation of the association between driving pressure during one-lung ventilation and the following outcomes:

(1) Duration of postoperative oxygen therapy (from extubation to discontinuation of oxygen therapy)
(2) Postoperative chest radiographic score assessed during hospitalization
(3) Postoperative length of hospital stay

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients aged 18 years or older
Patients scheduled to undergo lung resection surgery under one-lung ventilation (OLV)
Patients with an expected surgical duration of 3 hours or longer, including emergency surgeries
Patients at high risk for postoperative pulmonary complications (PPCs)

Key exclusion criteria

Pregnant or breastfeeding patients
Patients diagnosed with acute respiratory distress syndrome (ARDS) prior to surgery
Patients with heart failure classified as New York Heart Association (NYHA) class III or IV
Patients with increased intracranial pressure
Patients who received mechanical ventilation within 15 days prior to surgery
Patients with pneumothorax or giant bullae
Patients requiring oxygen therapy or continuous positive airway pressure
Patients with a history of lung resection
Patients in whom a bronchial blocker is used
Patients with a history of neuromuscular disease
Patients requiring extracorporeal circulation during surgery
Patients deemed inappropriate for inclusion by the investigators

Target sample size

350

Name of lead principal investigator

1st name	Takeshi
Middle name
Last name	Yoshida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

5650871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3133

Email

takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Name of contact person

1st name	Hiroki
Middle name
Last name	Taenaka

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

5650871

Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3133

Homepage URL

https://www.med.osaka-u.ac.jp/pub/anes/medical/surgery

Email

taenaka.hiroki.5h5@osaka-u.ac.jp

Institute

The University of Osaka

Institute

Department

Personal name

Organization

Takeda Science Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board, Osaka University Hospital

Address

2-2, Yamadaoka, Suita, Osaka, Japan

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大阪府）

Date of disclosure of the study information

2026

Year

09

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

12

Month

16

Day

Date of IRB

2025

Year

12

Month

23

Day

Anticipated trial start date

2026

Year

05

Month

11

Day

Last follow-up date

2028

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a multicenter prospective observational cohort study. Eligible participants will be consecutively enrolled from adult patients undergoing thoracic surgery requiring one-lung ventilation (OLV) at participating institutions during the study period, provided they meet the inclusion criteria and do not meet any exclusion criteria. Patient recruitment will be conducted from the date of institutional approval until December 31, 2028.

Collected data will include patient demographics, surgical variables, intraoperative ventilator parameters (including driving pressure, tidal volume, PEEP, and respiratory rate), arterial blood gas measurements, chest radiographic findings, postoperative pulmonary complication (PPC) scores, postoperative oxygen therapy data, and length of hospital stay.

Registered date

2026

Year

09

Month

09

Day

Last modified on

2026

Year

09

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069994