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.
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
- 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.
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
- 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.
- 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.
- 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
- 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 group | Role | What they receive |
|---|---|---|
| Group (A): Escalating PEEP | Active comparator | This 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 inflation | Active comparator | A 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.
Incidence of ICU admission
The incidence of post-operative patients requiring ICU admission
Measured: 6 months
Secondary outcomes (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.
- First posted26 Feb 2025
- Study start30 Jan 2025
- Primary completion27 Jul 2025 (estimated)
- Study completion27 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Nagah AL Shaer, Professor, Study chair, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06847412
- Acronym / sponsor ID
- FMASU MS 40/2025
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 27 Jul 2025 (estimated)
- Study completion
- 27 Jul 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): Escalating PEEP | Active comparator | Device: Escalating PEEPThis 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). |
| Group (B): Lung recruitment by Sustained inflation | Active comparator | Device: Sustained inflationA sustained inflation: Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Patient refusal.
- Pregnancy
- VATS procedure converted to open thoracotomy
- Patients have other lung diseases
- Patients ASA more than lll
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escalating PEEPTypically, 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). | Device | Group (A): Escalating PEEP |
| Sustained inflationSet the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s. | Device | Group (B): Lung recruitment by Sustained inflation |
Primary outcome
Incidence of ICU admission
Time frame: 6 months
The incidence of post-operative patients requiring ICU admission
1 secondary outcome
Incidence of pulmonary complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes. All dana will be shared once study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Nagah AL Shaer, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
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.