Laparoscopic SurgeryPEEP-EITNCT06850844
Recruitment Maneuvers and PEEP-guided Electrical Impedance Tomography for Abdominal Laparoscopic Surgery Patients
A study testing electrical impedance tomography and Conventional Ventilation in people with Laparoscopic Surgery and Positive End-Expiratory Pressure, run by Nguyen Dang Thu at 1 site in Vietnam.
Trial summary
Abdominal laparoscopy is widely utilized due to its benefits, including minimal invasiveness, improved cosmetic outcomes, and shorter hospital stays. However, the use of intraoperative pneumoperitoneum and general anesthesia with mechanical ventilation may lead to postoperative pulmonary complications, such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Positive End-Expiratory Pressure, Electrical Impedance Tomography
- What is being tested?
- electrical impedance tomography and Conventional Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2024to 30 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Scheduled for abdominal laparoscopy surgery
- At increased (i.e., intermediate or high) risk of postoperative pulmonary complications according to the "Assess Respiratory Risk in Surgical Patients in Catalonia" (ARISCAT) score (≥ 26 points)
- Signed written informed consent
Who cannot join
- Major previous lung surgery (e.g., lung resection)
- Severe chronic obstructive pulmonary disease and/or severe emphysema
- Increased intracranial pressure
- Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application)
- Presence of pneumothorax that is either undrained or newly occurred.
- Unstable hemodynamics with a mean arterial pressure < 60 mmHg and unresponsive to resuscitation measures, and/or heart rate < 60 bpm.
- Pregnancy.
- Severe neuromuscular disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Anesthesia Center, Bach Mai Hospital
Hanoi, 10000
Thang Toan Nguyen, Assoc. Prof; Ph.D; M.D, +84916874795, Thanggmhs@gmail.com
About this study
Official title: Impact of Recruitment Maneuvers and PEEP-guided Electrical Impedance Tomography on Regional Ventilation, Gas Exchange, and Pulmonary Mechanics in in Abdominal Laparoscopic Surgery Patients
Abdominal laparoscopy is widely utilized due to its benefits, including minimal invasiveness, improved cosmetic outcomes, and shorter hospital stays. However, the use of intraoperative pneumoperitoneum and general anesthesia with mechanical ventilation may lead to postoperative pulmonary complications, such as atelectasis. This condition can result in diminished respiratory mechanics and impaired gas exchange.
In recent years, intraoperative lung-protective mechanical ventilation techniques, including recruitment maneuvers (RMs) and positive end-expiratory pressure (PEEP) strategies, have gained popularity. These approaches aim to prevent the repeated collapse and reopening of alveoli, thereby reducing the risk of atelectasis. Nonetheless, determining the optimal PEEP level for individual patients remains a complicated and unresolved issue.
Read more
Electrical impedance tomography (EIT) is a bedside imaging technique that assesses regional ventilation distribution, providing a method for personalizing PEEP settings in mechanically ventilated patients. By addressing the competing risks of alveolar overdistension and collapse, EIT enhances the precision of PEEP titration.
This study aims to compare the effects of recruitment maneuvers and EIT-guided PEEP selection against conventional ventilation on regional ventilation, gas exchange, and pulmonary mechanics in patients undergoing abdominal laparoscopic surgery.
Read the detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of recruitment maneuvers and EIT-guided PEEP selection against conventional ventilation on regional ventilation, gas exchange, and pulmonary mechanics in patients undergoing abdominal laparoscopic surgery. Adult patients undergoing abdominal laparoscopic surgery will be enrolled in the study. Patients in the intervention group will receive intraoperative regular recruitment maneuvers and PEEP titrated using EIT with a stepwise decremental PEEP trial, while those in the control group will have a constant PEEP of 5 cmH2O. The primary outcomes are regional ventilation, blood oxygenation, and pulmonary mechanics. Secondary outcomes include hemodynamic effects, pneumothorax or barotrauma events during the intraoperative period, pulmonary complications during the first 5 days postoperative, and length of hospital stay.
Standard Ventilation Management:
Patients in both groups receive volume-controlled ventilation at the lowest possible inspired oxygen fraction (FiO2), with a minimum of 0.4, to maintain peripheral oxygen saturation (SpO2) above 92%. The inspiratory to expiratory ratio (I:E) is set at 1:2, and the respiratory rate is adjusted to achieve normocapnia, defined as an end-tidal carbon dioxide partial pressure between 35 and 45 mmHg. Tidal volume (VT) is set at 7 ml/kg predicted body weight (PBW), calculated using the following formula: for males, 50 + 0.91 × (height in centimeters - 152.4), and for females, 45.5 + 0.91 × (height in centimeters - 152.4).
Intervention Patients were randomized into either the intervention group or the control group.
Intervention Group: The individualized high PEEP with RMs group will commence with a PEEP of 5 cm H2O and will undergo an RM followed by a decremental PEEP trial. RMs are conducted only when hemodynamic stability is confirmed by the attending anesthesiologist. For this process, the ventilator is set to pressure-controlled ventilation mode, with a respiratory rate of 16 breaths per minute and ΔP=15 (ΔP is calculated by subtracting PEEP from the plateau pressure (Pplat)). In intervals of 5 breaths, PEEP is incrementally increased by 5 cm H2O, starting at 5 cm H2O and reaching up to 20 cm H2O. The decremental PEEP trial is immediately performed following the first RM, beginning at a PEEP of 20 cm H2O with a respiratory rate of 15 breaths per minute while maintaining the ventilator in pressure-controlled ventilation mode. Every 30 seconds, PEEP is decreased by increments of 2 cm H2O until it reaches a minimum of 6 cm H2O. This decremental PEEP trial is succeeded by a second RM, after which the individualized PEEP level will be established as determined by the decremental PEEP trial and sustained until the completion of ventilation.
Control Group: Patients will receive a constant PEEP of 5 cm H2O without RMs throughout the entire intraoperative ventilation period.
Rescue strategies Desaturation (defined as SpO2 ≤ 90% or if preoperative SpO2 < 90% an absolute decrease in SpO2 > 5%) If desaturations occur and there are no airway problems, severe hemodynamic impairment or ventilator malfunction, a rescue strategy is allowed by increasing FiO2 first, eventually followed by RM and PEEP increases.
Preapproved protocol deviations
If one of the following complications occurs and does not respond to conventional therapy, PEEP can be changed, according to the judgment of the anesthesiologist in charge:
(i) After PEEP titration, a mean arterial pressure (MAP) < 65 mmHg, lasting > 1 min and not responding to fluids and/or vasoactive drugs.
(ii) New arrhythmias not responding to the treatment suggested by the Advanced Cardiac Life Support guidelines.
(iii) Need for a dosage of vasoactive drugs at the highest level tolerated, according to the decision of the anesthesiologist in charge.
(iv) Need of massive transfusion, more than five units of blood to maintain hematocrit > 21% and hemoglobin> 7 mg/dL.
(v) Surgical complication resulting in a life-threatening situation. Any deviation from the protocol, excluding those mentioned above, is classified as a protocol violation. Protocol violations are to be reported and will be discussed with the data safety monitoring board.
- Being tested
- electrical impedance tomography, Conventional Ventilation
- Keywords
- Laparoscopic Surgery, Positive End-Expiratory Pressure, Recruitment Maneuver, electrical impedance tomography, blood oxygenation, regional ventilation, pulmonary mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance tomographyDevice
The individualized high PEEP with RMs group commences with a PEEP of 5 cm H2O and undergo an RM followed by a decremental PEEP trial. Pressure-controlled ventilation mode is set with a respiratory rate of 16 breaths per minute and ΔP=15 (ΔP is calculated by subtracting PEEP from the plateau pressure (Pplat). In intervals of 5 breaths, PEEP is incrementally increased by 5 cm H2O, starting at 5 cm H2O and reaching up to 20 cm H2O. The decremental PEEP trial is immediately performed following the first RM, beginning at a PEEP of 20 cm H2O with a respiratory rate of 15 breaths per minute. Every 30 seconds, PEEP is decreased by increments of 2 cm H2O until it reaches a minimum of 6 cm H2O. This decremental PEEP trial is succeeded by a second RM, after which the individualized PEEP level will be established as determined by the decremental PEEP trial and sustained until the completion of ventilation.
Conventional VentilationDevice
Ventilation is set in volume-controlled mode with a tidal volume of 7 ml/kg predicted body weight (PBW), the respiratory rate is adjusted to target normocapnia (end-tidal carbon dioxide partial pressure between 35 and 45 mmH), an inspiratory to expiratory ratio of 1:2, and a PEEP of 5 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Patients were applied recruitment maneuvers and EIT-guided PEEP during ventilation during general anesthesia. Receives: Device: electrical impedance tomography |
| Control Group | Placebo comparator | Patients will receive a constant PEEP of 5 cm H2O without RMs throughout the entire intraoperative ventilation period Receives: Device: Conventional Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Lung Ventilation
Evaluation of Ventilation Distribution With Electrical Impedance Tomography
Measured: During surgery
Oxygenation
PaO2/FiO2 will be evaluated via arterial blood gas analysis
Measured: During surgery, and at day 1 post-operative
Pulmonary Mechanic
Static Compliance
Measured: During surgery
Secondary outcomes (7)
Pneumothorax or barotrauma
New-onset of pneumothorax and barotrauma
Measured: During surgery
Hemodynamic instability
New-onset of Bradycardia and/or hypotension
Measured: During surgery
Respiratory failure
pO2 less than 60 mm Hg (or room air oxygen saturation less than or equal to 90%), pCO2 greater than 50 mm Hg with pH less than 7.35, and signs/symptoms of respiratory distress
Measured: Up to 5 days after surgery
Bronchospasm
Symptoms and signs of acute bronchospasm include wheezing, prolonged expiration, reduced breath sounds
Measured: Up to 5 days after surgery
Suspected pulmonary infection
A patient should be suspected of having pneumonia when the following signs and symptoms are present. An acute cough and one of the following: new focal chest signs; dyspnoea; tachypnoea; or fever >4 days
Measured: Up to 5 days after surgery
Pulmonary infiltrate
New pulmonary infiltrate of at least one complete lung segment with alveolar consolidation and excluding atelectasis; and presence of chest pain, temp T >38.5°C, tachypnea, wheezing, or cough.
Measured: Up to 5 days after surgery
Pleural effusion
New-onset of Pleural effusion
Measured: Up to 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Aug 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single center, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen Dang Thu
- Sponsor type
- University, hospital or other
- Collaborators
- Bach Mai Hospital, Hanoi Medical University
- Responsible party
- Sponsor-investigator, Nguyen Dang Thu, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850844
- Sponsor's protocol ID
- HuyenGMHS 5509/BM-HDDD
- Other IDs
- No.5509/BM-HDDD
- Acronym
- PEEP-EIT
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
PubMed 23196259Karsten J, Luepschen H, Grossherr M, Bruch HP, Leonhardt S, Gehring H, Meier T. Effect of PEEP on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography. Acta Anaesthesiol Scand. 2011 Aug;55(7):878-86. doi: 10.1111/j.1399-6576.2011.02467.x. Epub 2011 Jun 9.
PubMed 21658014Nestler C, Simon P, Petroff D, Hammermuller S, Kamrath D, Wolf S, Dietrich A, Camilo LM, Beda A, Carvalho AR, Giannella-Neto A, Reske AW, Wrigge H. Individualized positive end-expiratory pressure in obese patients during general anaesthesia: a randomized controlled clinical trial using electrical impedance tomography. Br J Anaesth. 2017 Dec 1;119(6):1194-1205. doi: 10.1093/bja/aex192.
PubMed 29045567Erlandsson K, Odenstedt H, Lundin S, Stenqvist O. Positive end-expiratory pressure optimization using electric impedance tomography in morbidly obese patients during laparoscopic gastric bypass surgery. Acta Anaesthesiol Scand. 2006 Aug;50(7):833-9. doi: 10.1111/j.1399-6576.2006.01079.x.
PubMed 16879466
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Recruitment Maneuvers and PEEP-guided Electrical Impedance Tomography on Regional Ventilation, Gas Exchange, and Pulmonary Mechanics in in Abdominal Laparoscopic Surgery Patients
- ClinicalTrials.gov ID
- NCT06850844
- Acronym / sponsor ID
- PEEP-EIT / HuyenGMHS 5509/BM-HDDD
- Keywords
- Laparoscopic Surgery, Positive End-Expiratory Pressure, Recruitment Maneuver, electrical impedance tomography, blood oxygenation, regional ventilation, pulmonary mechanics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nguyen Dang ThuUniversity, hospital or other
- Collaborators
- Bach Mai Hospital, Hanoi Medical University
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 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.
Abdominal laparoscopy is widely utilized due to its benefits, including minimal invasiveness, improved cosmetic outcomes, and shorter hospital stays. However, the use of intraoperative pneumoperitoneum and general anesthesia with mechanical ventilation may lead to postoperative pulmonary complications, such as atelectasis. This condition can result in diminished respiratory mechanics and impaired gas exchange.
In recent years, intraoperative lung-protective mechanical ventilation techniques, including recruitment maneuvers (RMs) and positive end-expiratory pressure (PEEP) strategies, have gained popularity. These approaches aim to prevent the repeated collapse and reopening of alveoli, thereby reducing the risk of atelectasis. Nonetheless, determining the optimal PEEP level for individual patients remains a complicated and unresolved issue.
Electrical impedance tomography (EIT) is a bedside imaging technique that assesses regional ventilation distribution, providing a method for personalizing PEEP settings in mechanically ventilated patients. By addressing the competing risks of alveolar overdistension and collapse, EIT enhances the precision of PEEP titration.
This study aims to compare the effects of recruitment maneuvers and EIT-guided PEEP selection against conventional ventilation on regional ventilation, gas exchange, and pulmonary mechanics in patients undergoing abdominal laparoscopic surgery.
Detailed description
This is a prospective, single-center, randomized controlled trial designed to evaluate the effects of recruitment maneuvers and EIT-guided PEEP selection against conventional ventilation on regional ventilation, gas exchange, and pulmonary mechanics in patients undergoing abdominal laparoscopic surgery. Adult patients undergoing abdominal laparoscopic surgery will be enrolled in the study. Patients in the intervention group will receive intraoperative regular recruitment maneuvers and PEEP titrated using EIT with a stepwise decremental PEEP trial, while those in the control group will have a constant PEEP of 5 cmH2O. The primary outcomes are regional ventilation, blood oxygenation, and pulmonary mechanics. Secondary outcomes include hemodynamic effects, pneumothorax or barotrauma events during the intraoperative period, pulmonary complications during the first 5 days postoperative, and length of hospital stay.
Standard Ventilation Management:
Patients in both groups receive volume-controlled ventilation at the lowest possible inspired oxygen fraction (FiO2), with a minimum of 0.4, to maintain peripheral oxygen saturation (SpO2) above 92%. The inspiratory to expiratory ratio (I:E) is set at 1:2, and the respiratory rate is adjusted to achieve normocapnia, defined as an end-tidal carbon dioxide partial pressure between 35 and 45 mmHg. Tidal volume (VT) is set at 7 ml/kg predicted body weight (PBW), calculated using the following formula: for males, 50 + 0.91 × (height in centimeters - 152.4), and for females, 45.5 + 0.91 × (height in centimeters - 152.4).
Intervention Patients were randomized into either the intervention group or the control group.
Intervention Group: The individualized high PEEP with RMs group will commence with a PEEP of 5 cm H2O and will undergo an RM followed by a decremental PEEP trial. RMs are conducted only when hemodynamic stability is confirmed by the attending anesthesiologist. For this process, the ventilator is set to pressure-controlled ventilation mode, with a respiratory rate of 16 breaths per minute and ΔP=15 (ΔP is calculated by subtracting PEEP from the plateau pressure (Pplat)). In intervals of 5 breaths, PEEP is incrementally increased by 5 cm H2O, starting at 5 cm H2O and reaching up to 20 cm H2O. The decremental PEEP trial is immediately performed following the first RM, beginning at a PEEP of 20 cm H2O with a respiratory rate of 15 breaths per minute while maintaining the ventilator in pressure-controlled ventilation mode. Every 30 seconds, PEEP is decreased by increments of 2 cm H2O until it reaches a minimum of 6 cm H2O. This decremental PEEP trial is succeeded by a second RM, after which the individualized PEEP level will be established as determined by the decremental PEEP trial and sustained until the completion of ventilation.
Control Group: Patients will receive a constant PEEP of 5 cm H2O without RMs throughout the entire intraoperative ventilation period.
Rescue strategies Desaturation (defined as SpO2 ≤ 90% or if preoperative SpO2 < 90% an absolute decrease in SpO2 > 5%) If desaturations occur and there are no airway problems, severe hemodynamic impairment or ventilator malfunction, a rescue strategy is allowed by increasing FiO2 first, eventually followed by RM and PEEP increases.
Preapproved protocol deviations
If one of the following complications occurs and does not respond to conventional therapy, PEEP can be changed, according to the judgment of the anesthesiologist in charge:
(i) After PEEP titration, a mean arterial pressure (MAP) < 65 mmHg, lasting > 1 min and not responding to fluids and/or vasoactive drugs.
(ii) New arrhythmias not responding to the treatment suggested by the Advanced Cardiac Life Support guidelines.
(iii) Need for a dosage of vasoactive drugs at the highest level tolerated, according to the decision of the anesthesiologist in charge.
(iv) Need of massive transfusion, more than five units of blood to maintain hematocrit > 21% and hemoglobin> 7 mg/dL.
(v) Surgical complication resulting in a life-threatening situation. Any deviation from the protocol, excluding those mentioned above, is classified as a protocol violation. Protocol violations are to be reported and will be discussed with the data safety monitoring board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, single center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: electrical impedance tomographyPatients were applied recruitment maneuvers and EIT-guided PEEP during ventilation during general anesthesia. |
| Control Group | Placebo comparator | Device: Conventional VentilationPatients will receive a constant PEEP of 5 cm H2O without RMs throughout the entire intraoperative ventilation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Scheduled for abdominal laparoscopy surgery
- At increased (i.e., intermediate or high) risk of postoperative pulmonary complications according to the "Assess Respiratory Risk in Surgical Patients in Catalonia" (ARISCAT) score (≥ 26 points)
- Signed written informed consent
Key exclusion criteria (8 listed)
- Major previous lung surgery (e.g., lung resection)
- Severe chronic obstructive pulmonary disease and/or severe emphysema
- Increased intracranial pressure
- Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application)
- Presence of pneumothorax that is either undrained or newly occurred.
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 |
|---|---|---|
| electrical impedance tomographyThe individualized high PEEP with RMs group commences with a PEEP of 5 cm H2O and undergo an RM followed by a decremental PEEP trial. Pressure-controlled ventilation mode is set with a respiratory rate of 16 breaths per minute and ΔP=15 (ΔP is calculated by subtracting PEEP from the plateau pressure (Pplat). In intervals of 5 breaths, PEEP is incrementally increased by 5 cm H2O, starting at 5 cm H2O and reaching up to 20 cm H2O. The decremental PEEP trial is immediately performed following the first RM, beginning at a PEEP of 20 cm H2O with a respiratory rate of 15 breaths per minute. Every 30 seconds, PEEP is decreased by increments of 2 cm H2O until it reaches a minimum of 6 cm H2O. This decremental PEEP trial is succeeded by a second RM, after which the individualized PEEP level will be established as determined by the decremental PEEP trial and sustained until the completion of ventilation. | Device | Intervention Group |
| Conventional VentilationVentilation is set in volume-controlled mode with a tidal volume of 7 ml/kg predicted body weight (PBW), the respiratory rate is adjusted to target normocapnia (end-tidal carbon dioxide partial pressure between 35 and 45 mmH), an inspiratory to expiratory ratio of 1:2, and a PEEP of 5 cmH2O. | Device | Control Group |
Primary outcome
Regional Lung Ventilation
Time frame: During surgery
Evaluation of Ventilation Distribution With Electrical Impedance Tomography
Oxygenation
Time frame: During surgery, and at day 1 post-operative
PaO2/FiO2 will be evaluated via arterial blood gas analysis
Pulmonary Mechanic
Time frame: During surgery
Static Compliance
7 secondary outcomes
Pneumothorax or barotrauma
Time frame: During surgery
Hemodynamic instability
Time frame: During surgery
Respiratory failure
Time frame: Up to 5 days after surgery
Bronchospasm
Time frame: Up to 5 days after surgery
Suspected pulmonary infection
Time frame: Up to 5 days after surgery
Pulmonary infiltrate
Time frame: Up to 5 days after surgery
Pleural effusion
Time frame: Up to 5 days after surgery
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 27 Feb 2025.
- Results publication: PubMed 23196259Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
- Results publication: PubMed 21658014Karsten J, Luepschen H, Grossherr M, Bruch HP, Leonhardt S, Gehring H, Meier T. Effect of PEEP on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography. Acta Anaesthesiol Scand. 2011 Aug;55(7):878-86. doi: 10.1111/j.1399-6576.2011.02467.x. Epub 2011 Jun 9.
- Results publication: PubMed 29045567Nestler C, Simon P, Petroff D, Hammermuller S, Kamrath D, Wolf S, Dietrich A, Camilo LM, Beda A, Carvalho AR, Giannella-Neto A, Reske AW, Wrigge H. Individualized positive end-expiratory pressure in obese patients during general anaesthesia: a randomized controlled clinical trial using electrical impedance tomography. Br J Anaesth. 2017 Dec 1;119(6):1194-1205. doi: 10.1093/bja/aex192.
- Results publication: PubMed 16879466Erlandsson K, Odenstedt H, Lundin S, Stenqvist O. Positive end-expiratory pressure optimization using electric impedance tomography in morbidly obese patients during laparoscopic gastric bypass surgery. Acta Anaesthesiol Scand. 2006 Aug;50(7):833-9. doi: 10.1111/j.1399-6576.2006.01079.x.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical impedance tomography and Conventional Ventilation in people with Laparoscopic Surgery and Positive End-Expiratory Pressure, run by Nguyen Dang Thu at 1 site in Vietnam.
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 4 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 27 Feb 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 Vietnam. 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. Some participants in this study may receive a placebo. 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 Thanh Huyen Thi Pham, M.D (+84989733699, drthanhhuyen368@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Lung Ventilation (time frame: During surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850844, which also lists 4 linked publications.
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 27 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.