Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients

NCT ID: NCT06805760

Last Updated: 2025-02-03

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-05-10

Brief Summary

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The purpose of this clinical trial was to understand the effects of variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and open surgery (Open Surgery). controlled ventilation (C-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) for open surgery, video-assisted thoracoscopic surgery, and segmental lung resection. VATS), segmentectomy (Segmentectomy), lobectomy (Lobectomy), and pneumonectomy (Pneumonectomy) on oxygen saturation and pulmonary complications, and length of hospitalization.

The main question it aims to answer is: variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV).Does it decrease patient oxygen saturation, and does it increase pulmonary complications, length of hospitalization? Researchers compared variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to compare them to see which mode of ventilation has the least physiologic disruption for the patient.

Participants will:

Select the appropriate surgical procedure according to the condition and be randomized to variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume- controlled ventilation (C-VCV), pressure-controlled ventilation (PCV), and were checked after surgery.

Patients' oxygen saturation, pulmonary complications, length of hospitalization were recorded

Detailed Description

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Conditions

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Lung Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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V-VCV Group

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.

Group Type EXPERIMENTAL

variable tidal volume ventilation (V-VCV)

Intervention Type OTHER

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.

PRVC Group

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\_max) and the minimum tidal volume (Vt\_min) was set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.

Group Type EXPERIMENTAL

pressure-regulated volume-controlled ventilation (PRVC)

Intervention Type OTHER

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\_max) and the minimum tidal volume (Vt\_min) was set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.

C-VCV Group

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.

Group Type EXPERIMENTAL

conventional volume-controlled ventilation (C-VCV)

Intervention Type OTHER

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.

PCV Group

The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.

Group Type EXPERIMENTAL

pressure-controlled ventilation (PCV)

Intervention Type OTHER

The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.

Interventions

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variable tidal volume ventilation (V-VCV)

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 41%.

Intervention Type OTHER

pressure-regulated volume-controlled ventilation (PRVC)

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW), the upper limit of peak inspiratory pressure was 30 cmH2O, the maximum tidal volume (Vt\_max) and the minimum tidal volume (Vt\_min) was set at 10-20% of the base tidal volume (Vt\_base). Respiratory Rate is 12, Inspiration to Expiration Ratio is 1:2, Positive End-Expiratory Pressure (PEEP) is 5cmH2O, and Inhaled Oxygen Concentration (FiO2) is 98%.

Intervention Type OTHER

conventional volume-controlled ventilation (C-VCV)

The initial tidal volume was set at 6-8 ml/kg IBW according to the Ideal Body Weight (IBW).The maximum tidal volume (Vt\_max) and minimum tidal volume (Vt\_min) were set at 10-20% of the basal tidal volume (Vt\_base). Respiratory Rate 12. Inspiratory Flow Rate (IFR) 60L/min, Inspiratory to Expiratory Ratio (IER) 1:2, Positive End-Expiratory Pressure (PEEP) 5cm water column, and Inhaled Oxygen Concentration (FiO2) 98%.

Intervention Type OTHER

pressure-controlled ventilation (PCV)

The inspiratory pressure level is set, usually with an initial value of 20 cmH2O, a respiratory rate of 12, an inspiratory/expiratory ratio of 1:2, a positive end-expiratory pressure (PEEP) of 5 cm water column, and an inspired oxygen concentration (FiO2) of 98%.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients requiring any of open surgery, television-assisted thoracoscopic surgery (VATS), segmental lung resection (Segmentectomy), lobectomy, and total lung resection (Pneumonectomy).
* Patients who are able to receive any of the ventilation modes of controlled ventilation (C - VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C - VCV), pressure-controlled ventilation (PCV), and variable tidal volume ventilation (V - VCV).

Exclusion Criteria

* Patients with severe cardiac, hepatic, renal, and other vital organ dysfunction
* Patients with mental illness or cognitive disorders that prevent them from understanding the study and cooperating with the study process.
* Patients with hematologic disorders
* Pregnant or breastfeeding females
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inner Mongolia Baogang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

Site Status

Countries

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China

Central Contacts

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Xiaguang XG Duan, Master's degree

Role: CONTACT

+86 13314720012

Facility Contacts

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Xiangyu XY Wang, Undergraduate

Role: primary

+86 0472 5992830

Other Identifiers

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2024-MER-313

Identifier Type: -

Identifier Source: org_study_id

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