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

Ventilation Strategies Impact on Oxygenation and Postoperative Pulmonary Complications in Lung Surgery Patients: a Prospective, Randomized, Triple-Blind Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Surgery
• Intervention / Treatment: Other: variable tidal volume ventilation (V-VCV); Other: pressure-regulated volume-controlled ventilation (PRVC); Other: conventional volume-controlled ventilation (C-VCV); Other: pressure-controlled ventilation (PCV)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaguang XG Duan, Master's degree; Phone Number: +86 13314720012; Email: alonlord2023@gmail.com

Study Locations

• China
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Inner Mongolia Baogang Hospital
      • Contact: Xiangyu XY Wang, Undergraduate; Phone Number: +86 0472 5992830; Email: KevinDuan0901@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%.	Other: 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%.
Experimental: 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%.	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%.
Experimental: 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%.	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%.
Experimental: 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%.	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
oxygen saturation	One week postoperative

Collaborators and Investigators

• Sponsor: Inner Mongolia Baogang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-MER-313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: January 2026-January 2036
• IPD Sharing Access Criteria: A proposal that describes planned analyses must be submitted or whether a data sharing agreement must be signed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No