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HypoxemiaDPVNCT06361420

Driving Pressure-guided Lung Protective Ventilation

A study testing Driving pressure-guided positive end expiratory pressure, Optimal oxygenation-guided positive end expiratory pressure and Ventilation strategy in people with Hypoxemia and Ventilator Lung, run by Yong Lin, PhD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Hypoxemia, Ventilator Lung
What is being tested?
Driving pressure-guided positive end expiratory pressure, Optimal oxygenation-guided positive end expiratory pressure and Ventilation strategy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
26 Jan 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong Lin, MD contact

13805064575

birdman1983@163.com

China1 site, 1 recruiting
  • Fujian medical university union hospital

    Fuzhou, Fujian, 350001

    Yong Lin, MD, 13805064575, birdman1983@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Postoperative hypoxemia is defined as 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. Acute type A aortic dissection is a lethal disease requiring emergency surgery. Compared with non-cardiac surgery, hypoxemia frequently occurs after surgical repair for acute type A aortic dissection which has been reported to be 52%-67.6%, and the possible mechanisms are as followed: (1) systemic inflammatory reaction induced by massive thrombosis formation and long duration of extracorporeal circulation; (2) ischemia-perfusion injury in lung; and (3) a massive perioperative transfusion. Postoperative hypoxemia has been reported to be associated with prolonged duration of extubation, length of stay in ICU and respiratory failure, which contributes a high mortality of 20% to 44%.

Driving pressure, defined as the difference between platform airway pressure and positive end-expiratory pressure, was first introduced by Amato and his colleagues in their meta-analysis study on acute respiratory distress syndrome in 2015, demonstrating that driving pressure was most strongly associated with survival among various ventilation parameters. A lower driving pressure has been verified to be closely relative to an ameliorative prognosis after surgery. However, controversy persists regarding whether driving pressure-guided ventilation can decrease the incidences of postoperative hypoxemia and other pulmonary complications in the patients underwent surgical repair of acute type A aortic dissection.

Given the need for additional evidence to confirm the relationship between driving pressure and postoperative hypoxemia in the patients with acute type A aortic dissection, this open-label, randomized control clinical trial aims to assess the efficacy and safety of the driving pressure-guided lung protective ventilation strategy in preventing hypoxemia and other pulmonary complications after the surgical repair for acute type A aortic dissection.

Being tested
Driving pressure-guided positive end expiratory pressure, Optimal oxygenation-guided positive end expiratory pressure, Ventilation strategy, Management of hypoxemia
Keywords
Driving Pressure, Lung Protective Ventilation, Aortic Dissection, Hypoxia, Postoperative Pulmonary Complications
Medical subject headings
Hypoxia, Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Driving pressure-guided positive end expiratory pressureProcedure or surgery

    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.

  • Optimal oxygenation-guided positive end expiratory pressureProcedure or surgery

    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.

  • Ventilation strategyProcedure or surgery

    Also called Same part of ventilation strategy between the two groups

    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%.

  • Management of hypoxemiaProcedure or surgery

    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.

Study groups in NCT06361420
Study groupRoleWhat they receive
Driving pressure-guided lung protective ventilation during the surgeryExperimentalA 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.
Receives: Procedure: Driving pressure-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia
Conventional lung protective ventilationOtherPositive end expiratory pressure will be maintained at the level facilitating optimal oxygenation during the off-pump period.
Receives: Procedure: Optimal oxygenation-guided positive end expiratory pressure; Procedure: Ventilation strategy; Procedure: Management of hypoxemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 7 days after surgery

Secondary outcomes (8)
  1. The trend of perioperative oxygenation function

    An automated blood gas analyzer will be applied for arterial blood gas analyses, with the time points: T1 (before surgery), T2 (after intubation), T3 (withdrawal from cardiopulmonary bypass), T4 (end of surgery), T5 (postoperative day 1), T6 (postoperative day 3), T7 (postoperative day 5), and T8 (postoperative day 7).

    Measured: Within 7 days after surgery

  2. Postoperative pulmonary complications except hypoxemia

    Postoperative pulmonary complications are defined as any postoperative respiratory system complication that occurs from admission to the intensive care unit to 7 days post-surgery, encompassing (1) respiratory infection, (2) respiratory failure, (3) bronchospasm, (4) atelectasis, (5) pleural effusion, (6) pneumothorax, and (7) aspiration pneumonitis.

    Measured: Within 7 days after surgery

  3. Early/late death

    Early death was defined as any death occurring within 72 hours of surgery, while late death was considered for deaths occurring within 30 days after the surgery was scheduled.

    Measured: Within 30 days after surgery

  4. Vasoactive-inotropic score at the end of surgery

    The vasoactive-inotropic score is the sum of the dosages of frequently used vasoactive or inotropic agents according to the weighted values of the enrolled patients. Vasoactive-Inotropic Score = dopamine dose (μg·kg-1·min-1) + dobutamine dose (μg·kg-1·min-1) + 100 × epinephrine dose (μg·kg-1·min-1) + 10 × phosphodiesterase inhibitor (milrinone or olprinone) dose (μg·kg-1·min-1) + 100 × norepinephrine dose (μg·kg-1·min-1) +10000 × vasopressin dose (U·kg-1·min-1).

    Measured: Within 7 days after surgery

  5. Postoperative adverse cardiovascular events

    The postoperative adverse cardiovascular events include new-onset lethal arrhythmias (supraventricular/ventricular tachycardia, ventricular fibrillation, or Adams-Stokes syndrome), acute myocardial infarction, cardiogenic shock, and thrombotic or embolic events.

    Measured: Within 7 days after surgery

  6. Length of stay in intensive care unit

    The duration from admission to discharge of the ICU

    Measured: Within 30 days after surgery

  7. Ventilation assistance time

    Duration from the end of the surgery to extubation.

    Measured: Depending on the time point of extubation, not exceeding 30 days

  8. Postoperative extrapulmonary complications

    Postoperative extrapulmonary complications include tracheotomy, rethoracotomy for exploration, wound infection, sepsis, gastrointestinal haemorrhage, and neurological complications (such as delayed recovery, delirium, cognitive dysfunction, coma, new-onset stroke, and syncope)

    Measured: Within 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start26 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
open, randomised control trial
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361420
Sponsor's protocol ID
2023YF051-01
Acronym
DPV
Status last verified
Aug 2025
First submitted
10 Mar 2024
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Driving pressure-guided positive end expiratory pressure, Optimal oxygenation-guided positive end expiratory pressure and Ventilation strategy in people with Hypoxemia and Ventilator Lung, run by Yong Lin, PhD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yong Lin, MD (13805064575, birdman1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative hypoxemia (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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