Driving Pressure-guided Lung Protective Ventilation

NCT06361420 | Recruiting

• 1 other identifier: 2023YF051-01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The study, named as "The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection: an open-label, randomized control clinical trial", aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection. The primary outcomes is the incidence of postoperative hypoxemia (a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93% at any concentration of inspiratory oxygen) within 7 days after the surgery.

Conditions

Hypoxemia; Ventilator Lung

Keywords

Driving Pressure; Lung Protective Ventilation; Aortic Dissection; Hypoxia; Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative hypoxemia

  Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a pulse oximetry less than 93% at any concentration of inspiratory oxygen that occurred from admission to the operating room to 7 days post-surgery.

  Within 7 days after surgery

Secondary Outcomes (8)

• The trend of perioperative oxygenation function

  Within 7 days after surgery

• Postoperative pulmonary complications except hypoxemia

  Within 7 days after surgery

• Early/late death

  Within 30 days after surgery

• Vasoactive-inotropic score at the end of surgery

  Within 7 days after surgery

• Postoperative adverse cardiovascular events

  Within 7 days after surgery

Study Arms (2)

Driving pressure-guided lung protective ventilation during the surgery

EXPERIMENTAL

A 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter.

Procedure: Driving pressure-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia

Conventional lung protective ventilation

OTHER

Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.

Procedure: Optimal oxygenation-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia

Interventions

Driving pressure-guided positive end expiratory pressure PROCEDURE

The positive end expiratory pressure setting rules are as follows: a 10-cycle experimental ventilation will be carried out at each level of positive end expiratory pressure after intubation, and the driving pressure of the last cycle will be recorded. The positive end expiratory pressure value corresponding to the lowest driving pressure is recognised as the optimal ventilation parameter. Partial pressure of carbon dioxide monitoring is employed to determine the tidal volume and respiratory rate. Inspiration/expiration pattern is adjusted based on the preoperative small airway condition. This parameter is subject to modification upon cessation of ventilation, ICU admission, and every morning throughout the ventilation period. During cardiopulmonary bypass, mechanical ventilation is maintained using the low-level parameters.

Driving pressure-guided lung protective ventilation during the surgery

Optimal oxygenation-guided positive end expiratory pressure PROCEDURE

Positive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period. Partial pressure of carbon dioxide monitoring is employed to determine the tidal volume and respiratory rate. Inspiration/expiration pattern is adjusted based on the preoperative small airway condition. This parameter is subject to modification upon cessation of ventilation, ICU admission, and every morning throughout the ventilation period. During cardiopulmonary bypass, mechanical ventilation is maintained using the low-level parameters.

Conventional lung protective ventilation

Ventilation strategy PROCEDURE

A Pressure regulated volume control mode is used in the patients before extubation. The ventilation target are: (1) a pulse oximetry ≥ 90% or a partial pressure of arterial oxygen ≥ 60mm Hg; (2) a partial pressure of arterial carbon dioxide: 35 \~ 50 mm Hg and (3) a pondus hydrogenii (pH) value \> 7.20. The ventilation parameters are: (1) tidal volume: 6 \~ 8 mL/Kg predictive body weight; (2) respiratory rate 10 \~ 15 cycles per minute; (3) inspiratory/expiratory ratio: 1:1.5 (1:2.5 - 1:3 in the patients with chronic obstructive pulmonary disease); positive end expiratory pressure: 0 \~ 8 cm centimeter water column. On-pump ventilation parameters are: (1) tidal volume: 4 mL/Kg predictive body weight; (2) respiratory rate: 4 circles per minute; (3) positive end-expiratory pressure: 4 cm centimeter water column; (4) inspiratory oxygen fraction: 21%.

Also known as: Same part of ventilation strategy between the two groups

Conventional lung protective ventilation; Driving pressure-guided lung protective ventilation during the surgery

Management of hypoxemia PROCEDURE

Management of hypoxemia will be initiated immediately through the following steps: (1) carefully checking anaesthesia apparatus malfunction, airway normality, and monitoring accuracy; (2) improving cardiac function, correcting fluid overload, and alleviating systemic inflammation; (3) performing alveolar recruitment manoeuvres as described above; (4) increasing the tidal volume and positive end expiratory pressure within the upper limits; (5) increasing the respiratory rate while addressing concurrent hypercapnia; (6) titrating the fraction of inspiratory oxygen until the pulse oximetry reaches or exceeds 90%; and (7) considering the use of extracorporeal membrane oxygenation if any following situations occurred 14: (a) a partial pressure of arterial oxygen \< 50 mm Hg for more than 3 hours; (b) a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio \< 80 mm Hg for more than 6 hours; or (c) a critical respiratory acidosis for more than 6 hours.

Conventional lung protective ventilation; Driving pressure-guided lung protective ventilation during the surgery

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to sign Informed Consent and Release of Medical Information Forms;
• Age ≥ 14 years and ≤ 70 years old;
• Being confirmed the diagnosis by chest computed tomography angiography and receiving the surgical repair of acute type A aortic dissection.

You may not qualify if:

• Age \< 14 years or \> 70 years old;
• Sepsis before surgery;
• Chronic pulmonary disease including lung infection or asthma requiring long-term pharmacotherapy;
• History of lung tumor;
• Obstructive sleep apnea hypopnea syndrome requiring long-term noninvasive mechanical ventilation support;
• Heart failure requiring catecholamines or invasive mechanical ventilation support;
• Body mass index \> 30 Kg·m-2;
• Being reluctance to participate this study.

Sponsors & Collaborators

• Yong Lin, PhD: lead

Study Sites (1)

Fujian medical university union hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Hypoxia; Aortic Dissection

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Yong Lin, MD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Lin, MD

CONTACT

13805064575; birdman1983@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Model Details: open, randomised control trial

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 11, 2024
• Study Start: January 26, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)