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Protective Ventilation During Pulmonary Lobectomy

The Effect of Protective Ventilation During Pulmonary Lobectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03174743
Enrollment
120
Registered
2017-06-02
Start date
2017-06-02
Completion date
2018-07-01
Last updated
2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Complication, Thoracic Surgery, Inflammation

Brief summary

The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.

Detailed description

The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.

Interventions

PROCEDUREConvential Ventilation 1

High tidal volume, moderate inspired oygen fraction (FiO2).

PROCEDUREConvential Ventilation 2

High tidal volume, high inspired oygen fraction (FiO2).

Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.

Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.

Sponsors

Xuzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1.20 Years and older 2.Patients undergoing pulmonary lobectomy

Exclusion criteria

1. Emergency surgery 2. Pulmonary hypertension 3. Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values 4. Coagulation disorder 5. Pulmonary or extrapulmonary infections 6. History of treatment with steroid in 3 months before surgery 7. History of recurrent pneumothorax 8. History of lung resection surgery

Design outcomes

Primary

MeasureTime frameDescription
The proportion of patients with pulmonary complicationup to postoperative 3daysThe number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.

Secondary

MeasureTime frameDescription
PaO2 /FiO210 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
respiratory compliance10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilationDynamic compliance, Static compliance
IL610 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL1010 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

Countries

China

Contacts

Primary ContactLiu Su Liu, M.D/Ph.D
xyfymzk@163.com86-18118309692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026