AzTrials
AzTrials

HypoxemiaNCT06847412

The Effectiveness of Two Distinct Ventilation Strategies Escalating Positive End Expiratory Pressure (PEEP) and Lung Recruitment Maneuvers in Improving Oxygenation

A study testing Escalating PEEP and Sustained inflation in people with Hypoxemia and COPD, run by Ain Shams University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study evaluates and compares the effectiveness of two distinct ventilation strategies-escalating PEEP and lung recruitment maneuvers-in improving oxygenation (i.e., managing hypoxemia) in COPD patients undergoing VATS. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Hypoxemia, COPD
What is being tested?
Escalating PEEP and Sustained inflation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
30 Jan 2025to 27 Jul 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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥ 20 years and </=60 years.
  • Both sex.
  • Patients American Society of Anesthesiologists Physical Status (ASA) Il to IIl.
  • A written, valid, and informed consent
  • Mild to moderate COPD patients
  • BMI less than 4

Who cannot join

  • Patient refusal.
  • Pregnancy
  • VATS procedure converted to open thoracotomy
  • Patients have other lung diseases
  • Patients ASA more than lll
  • Patients with cardiac diseases affecting systolic \& diastolic functions

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams university

    Cairo, Egypt, 11111

Other trials in Egypt

About this study

Official title: Comparative Study of Escalating PEEP (Positive End Expiratory Pressure) vs. Lung Recruitment by Sustained Inflation Strategies for Managing Hypoxemia in COPD Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

This study evaluates and compares the effectiveness of two distinct ventilation strategies-escalating PEEP and lung recruitment maneuvers-in improving oxygenation (i.e., managing hypoxemia) in COPD patients undergoing VATS.

Read the detailed description
  1. Preoperative settings :
  • Written informed consent will be obtained from all participants prior to the study.
  • Pre-operative optimisation of patients include cessation of smoking, improvement of pulmonary functions using bronchodilators and steroids, pre-operative chest physiotherapy and training of patient with lung expansion manuoevers. Reversible components of COPD such as bronchospasm, infections, and pulmonary oedema should be actively looked for and treated aggressively 9.
  • Detection of severity of COPD by using The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system categorizes airflow limitation into stages. In patients with FEV₁/FVC <0.7:
  • GOLD 1 - mild: FEV₁ ≥80% predicted
  • GOLD 2 - moderate: 50% ≤ FEV₁ <80% predicted
  • GOLD 3 - severe: 30% ≤ FEV₁ <50% predicted
  • GOLD 4 - very severe: FEV₁ <30% predicted 10.
  • Preoperative assessment evaluates lung mechanics, parenchymal function, and cardiopulmonary reserve to determine a patient's suitability for surgery. Lung mechanics, including forced expiratory volume in 1 second (FEV1), maximum voluntary ventilation, forced vital capacity, and residual volume/total lung capacity (RV/TLC) ratio, provide insights into respiratory function. An FEV1 greater than 60% indicates potential tolerance for anatomic lobe resection. An FEV1 of less than 30% suggests postoperative ventilator or supplemental oxygen dependence. In FEV1s less than 60%, a ventilation-perfusion scan (VQ scan) may calculate a postoperative FEV1, with values above 35% (and up to 40%), suggesting adequate postoperative pulmonary reserve. DLCO, measuring gas diffusion, ideally exceeds 40% for surgery. Cardiopulmonary exercise testing assesses overall reserve, with a maximum rate of oxygen (O2) your body can use during exercise (VO2) greater than 10 mL/min/kg, indicating suitability for surgery 2.
  • Preoperative assessment for VATS also involves evaluating blood counts for indications of polycythemia or infection. Chest x-rays and CT scans provide anatomical details for surgical planning. Arterial blood gases identify patients at risk for postoperative complications; a partial pressure of carbon dioxide (CO2) more than 50 mm Hg or a partial pressure of O2 less than 60 mm Hg indicates vulnerability 2.
  1. Intraoperative settings:

Electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximeter (SpO2) will be applied, and baseline readings will be taken before induction.

Anaesthesia will be induced after a period of preoxygenation with 100% oxygen for 2-3 minutes with intravenous injection of fentanyl 2 µg/kg, propofol 2 mg/kg and a muscle relaxant (Atracurium) 0.5 mg/kg after loss of patient consciousness. Lung isolation is achieved using a double-lumen endotracheal tube, Fiberoptic bronchoscopy is typically used to guide and confirm the placement and positioning of the tube 11.

Patients often requires the placement of invasive monitoring devices, such as invasive blood pressure (IBP) lines and central venous lines (CVL).

Anaesthesia will be maintained by 1-2 % of isoflurane in 50% oxygen/air mixture according to oxygen state and 0.1 mg/kg atracurium, ventilation parameters that maintain normocapnia (CO2 between 35- 40 mmHg). Fluids as crystalloids used by a fluid chart for the deficit and maintenance as needed.

The surgery typically begins with the patient positioned in a full lateral decubitus posture tailored to the side of the operation or in a supine position with appropriate support to access the chest.

Ventilatory setting:

Typically, an initial PEEP of 5 cm H₂O is used in all patients,

Group A:

PEEP is typically increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).

Group B:

A sustained inflation:

Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.

  1. Postoperative settings:

Follow up patients in recovery room whether transferred to ICU or to Ward, data will be recorded at the following times 1 h, 2 h, 6 h, 12 h, and 24 h. Both groups will be compared to each other according to the following variables:

  • Hypoxemia
  • The Need for mechanical ventilation
Conditions
Hypoxemia, COPD
Being tested
Escalating PEEP, Sustained inflation
Medical subject headings
Hypoxia, Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Escalating PEEPDevice

    Typically, an initial PEEP of 5 cm H₂O, then PEEP is increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).

  • Sustained inflationDevice

    Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.

Study groups in NCT06847412
Study groupRoleWhat they receive
Group (A): Escalating PEEPActive comparatorThis group will undergo VATS \& one hypoxemia started PEEP is typically increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).
Receives: Device: Escalating PEEP
Group (B): Lung recruitment by Sustained inflationActive comparatorA sustained inflation: Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.
Receives: Device: Sustained inflation

What is being measured

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

  1. Incidence of ICU admission

    The incidence of post-operative patients requiring ICU admission

    Measured: 6 months

Secondary outcomes (1)
  1. Incidence of pulmonary complications

    Intraoperative Hemodynamic instability, hypoxemia \& Hypercapnia Post operative Needs of mechanical ventilation. Post operative pulmonary complications.

    Measured: 6 months

Timeline

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

  1. First posted26 Feb 2025
  2. Study start30 Jan 2025
  3. Primary completion27 Jul 2025 (estimated)
  4. Study completion27 Jul 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06847412
Sponsor's protocol ID
FMASU MS 40/2025
Status last verified
Jan 2025
First submitted
21 Feb 2025
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All dana will be shared once study is completed

Questions about this trial

What is this clinical trial studying?

A study testing Escalating PEEP and Sustained inflation in people with Hypoxemia and COPD, run by Ain Shams University at 1 site in Egypt.

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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 Mar 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 Egypt. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ICU admission (time frame: 6 months). 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 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in