AtelectasisRESPIRA-EITNCT06538740
Impact of High Versus Lower Oxygen Fraction Prior to Extubation on Postoperative Pulmonary Atelectasis Measured With EIT
A study testing Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation in people with Atelectasis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Elective surgery with general anesthesia and endotracheal intubation
- Expected duration of surgery 1-5 hours
- Consent obtained from patient
Who cannot join
- Patients with inability to give written informed consent
- American Society of Anesthesiologists (ASA) physical status> IV
- Morbid obesity BMI > 40
- Suspected pregnancy and lactation
- Cardiac or thoracic surgery
- Patients with thoracic epidural catheters
Show all 9Show fewer
- Patients with active implantable devices, such as pacemakers, cardioverter defibrillators, or neurostimulators
- Compromised airways
- Impaired oxygenation at baseline or during surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Trial Investigating the Impact of High Versus Lower Oxygen Fraction During Extubation on Postoperative Pulmonary Atelectasis Measured With Electrical Impedance Tomography
Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration, as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association, standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase, but the patient is still exposed to the risk of atelectasis formation.
This study aims to investigate the hypothesis of whether the utilization of reduced inspiratory oxygen concentration before extubation (70% or 40% compared to 100%) reduces atelectasis formation. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia.
Of note, both concentrations are still higher than when breathing room air in, which has of 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO₂), heart rate, and blood pressure are recorded, and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated time points during the procedure. Anesthesia care providers are asked to document procedural, patient, and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (<90% SpO₂), incidence of re-intubation or non-invasive ventilation, and the Post-anesthesia Care Unit (PACU) length of stay.
Read the detailed description
This study is a single blinded randomized controlled trial with and aims to assess whether the use of 100% oxygen before extubation favors postoperative atelectasis formation compared to the use of lower oxygen concentrations whilst still ensuring patient safety. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia. Patients are randomized to either the control group or the intervention group.
The randomization scheme is developed by a non-blinded statistician using the Statistical Analysis Software (SAS) and uploaded to the Research Electronic Data Capture (REDCap) randomization module, enabling delegated team members to generate sequential allocations for enrolled subjects.
Screening of potential study subjects is performed by the PI. The patient is asked to participate in the study by the PI or co-investigator and the study design and procedures are explained to the patient, while they are still in the holding area on the day of the procedure.
The patients in both groups (control and intervention) are equipped with the EIT belt as well as an additional SpO₂ recording device before induction and intubation. After onset of mechanical ventilation as per institutional standards, an inspiratory oxygen concentration of 50% is aimed. Actual oxygen concentration as well as any administration of drugs remain at the discretion of the anesthesia care provider. At the end of the procedure, before the initiation of volatile anesthetic washout, fresh gas flow is increased to 15 liters per minute (or the highest fresh gas flow allowed at the respective anesthesia machine if 15 liters per minute cannot be achieved), and a fraction of inspired oxygen (FiO₂) of either 70% (intervention group) or 100% (control group) for the first 24 randomized patients, and of either 40% (intervention group) or 100% for the subsequent 24 randomized patients is applied.
EIT measurements take place at 6 designated time points before, during and after the procedure. These time points are: Pre-induction, after intubation, just before washout, pre-extubation, one minute after extubation and 60 minutes after extubation in the PACU.
The primary outcome for the study is the Center of Ventilation (CoV), measured through electrical impedance tomography (EIT) compared at one minute after extubation between the control group and intervention groups.
Secondary outcomes include the homogeneity index, and the distribution of lung aeration measured by EIT. In addition, we measure the peripheral oxygen concentration during the whole interventional period and during the PACU stay to evaluate any occurrence of desaturation (SpO₂ <90%) within the first 60 minutes after extubation in the PACU. The incidence of re-intubation or the need for non-invasive ventilation in the next 7 days and an unplanned admission, to either ICU, Intermediate Care Unit (IMC) or the normal ward, as well as the length of stay in the PACU are other clinical secondary outcomes compared between the groups. Subsequent analyses will assess differences between the 70% and 40% oxygen subgroups within the intervention arm to evaluate potential dose-dependency.
- Conditions
- Atelectasis
- Being tested
- Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation
- Keywords
- Pulmonary Atelectasis [C08.381.730], Oxygen [D01.268.185.550, D01.362.670], Electrical impedance tomography, Center of Ventilation, lung aeration, anesthesia
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubationProcedure or surgery
The investigated intervention is the application of 70% inspired oxygen compared to 100% inspired oxygen during the anesthetic washout, right before extubation of the patient for the first 24 enrolled patients, and 40% inspired oxygen compared to 100% inspired oxygen for the subsequently enrolled 24 patients. Before and after the intervention EIT measurements are performed at designated time points to assess lung aeration and calculate the center of ventilation. This information allows assumptions on atelectasis formation in the patients' lung.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Ventilating the patient with 100% oxygen concentration during the wash out phase, before extubation |
| Intervention group | Active comparator | Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation Receives: Procedure: Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The shift of Center of Ventilation (CoV), measured through Electrical Impedance Tomography (EIT) in %.
The Center of Ventilation (CoV) is a variable based on the EIT. It is calculated after the initial measurements and defines the most ventilated area of the lung. Assumptions on atelectasis formation can be drawn when the CoV shifts to more ventral areas than measured before. Primary outcome is the absolute difference between the first measurement (before induction) and the measurement directly after extubation in %.
Measured: The CoV is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU. The primary outcome is the difference between pre-induction and 1 min post-extubation.
Secondary outcomes (6)
The 1st secondary outcome is the variation of the inhomogeneity index within each patient, measured through Electrical Impedance Tomography (EIT).
The inhomogeneity index is a variable based on the EIT and is calculated after the initial measurements. It defines the homogeneity of the aeration throughout the whole ventilated area and provides information on potential atelectasis formation or overventilation in certain lung areas. The outcome is the variation of the inhomogeneity index within each patient.
Measured: The inhomogeneity index is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU.
The 2nd secondary outcome is the distribution of lung aeration, measured through Electrical Impedance Tomography (EIT).
The distribution is a variable based on the EIT and can be calculated after the initial measurements. It defines the distribution of the lung aeration throughout the whole ventilated area and can give information on potential atelectasis formation in the lung.
Measured: The distribution of lung aeration is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU.
Minutes of hypoxemia in the first 60 minutes after extubation
It is determined as SpO2 < 90% for more than two minutes throughout the stay in the PACU in the first 60 minutes after extubation.
Measured: The SpO2 data analysis starts with the time the patient enters the PACU and is continued until the patient is discharged from the PACU, which is typically one to two hours after the end of surgery.
Re-intubation or the need for unplanned non-invasive ventilation within 7 days.
It is determined as re-intubation or the need for unplanned non-invasive ventilation (NIV).
Measured: 7 days post-operative
Unplanned admission to either ICU, IMC or a normal unit.
Number of patients that experience unplanned admission to either ICU, IMC or a normal unit after their PACU stay.
Measured: Unplanned admission to either ICU, ICM or a normal unit after the PACU stay is determined in the time frame after end of surgery and up to 7 days after the surgery.
Length of stay in the PACU
It is determined as the length of stay in the PACU in minutes.
Measured: The length of stay in the PACU is measured in minutes from admission to discharge from the PACU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start27 Sep 2024
- Primary completion15 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single blinded, randomized, trial comparing two study groups ("intervention" and "control")
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian S Schaefer, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538740
- Sponsor's protocol ID
- IRB: 2023P000223
- Acronym
- RESPIRA-EIT
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161Riva T, Pascolo F, Huber M, Theiler L, Greif R, Disma N, Fuchs A, Berger-Estilita J, Riedel T. Evaluation of atelectasis using electrical impedance tomography during procedural deep sedation for MRI in small children: A prospective observational trial. J Clin Anesth. 2022 May;77:110626. doi: 10.1016/j.jclinane.2021.110626. Epub 2021 Dec 10.
PubMed 34902800Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186/1471-2253-14-51. eCollection 2014.
PubMed 25018668Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
PubMed 14693669Benoit Z, Wicky S, Fischer JF, Frascarolo P, Chapuis C, Spahn DR, Magnusson L. The effect of increased FIO(2) before tracheal extubation on postoperative atelectasis. Anesth Analg. 2002 Dec;95(6):1777-81, table of contents. doi: 10.1097/00000539-200212000-00058.
PubMed 12456458Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3.
PubMed 7760608Reber A, Engberg G, Wegenius G, Hedenstierna G. Lung aeration. The effect of pre-oxygenation and hyperoxygenation during total intravenous anaesthesia. Anaesthesia. 1996 Aug;51(8):733-7. doi: 10.1111/j.1365-2044.1996.tb07885.x.
PubMed 8795314
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Investigating the Impact of High Versus Lower Oxygen Fraction During Extubation on Postoperative Pulmonary Atelectasis Measured With Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT06538740
- Acronym / sponsor ID
- RESPIRA-EIT / IRB: 2023P000223
- Conditions
- Atelectasis
- Keywords
- Pulmonary Atelectasis [C08.381.730], Oxygen [D01.268.185.550, D01.362.670], Electrical impedance tomography, Center of Ventilation, lung aeration, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 6 Aug 2024 (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.
Patients undergoing general anesthesia require mechanical ventilation (artificial delivery of air and oxygen to their lungs). It is well known that during mechanical ventilation, so-called atelectasis formation occurs. This is a condition characterized by partial or complete collapse of lung tissue that can result in a reduction in oxygen uptake through the lung. A known risk factor for atelectasis formation during mechanical ventilation is the utilization of high oxygen concentration, as the oxygen molecules are absorbed in the lung, which then can lead to collapse of the tissue. Despite the proven association, standard operating procedure at the end of anesthesia still requires utilization of 100% oxygen. Its justification is the goal to ensure sufficient oxygenation throughout the extubation phase. However, clinical observation doesn't show a lack of oxygenation in this phase, but the patient is still exposed to the risk of atelectasis formation.
This study aims to investigate the hypothesis of whether the utilization of reduced inspiratory oxygen concentration before extubation (70% or 40% compared to 100%) reduces atelectasis formation. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia.
Of note, both concentrations are still higher than when breathing room air in, which has of 21% oxygen. During the intervention, parameters such as the oxygen content in the blood (oxygen saturation, SpO₂), heart rate, and blood pressure are recorded, and atelectasis formation is measured using a technique called electrical impedance tomography (EIT). EIT measurements are performed at designated time points during the procedure. Anesthesia care providers are asked to document procedural, patient, and ventilator data in a questionnaire. Secondary outcomes are the homogeneity and distribution of air measured with EIT, as well as some clinical outcomes including post-extubation desaturation (<90% SpO₂), incidence of re-intubation or non-invasive ventilation, and the Post-anesthesia Care Unit (PACU) length of stay.
Detailed description
This study is a single blinded randomized controlled trial with and aims to assess whether the use of 100% oxygen before extubation favors postoperative atelectasis formation compared to the use of lower oxygen concentrations whilst still ensuring patient safety. The study was originally planned to randomize 24 patients to either 70% or 100% inspiratory oxygen concentration at the end of anaesthesia. After completion of this first phase, the study was amended to enroll another 24 patients randomized to 40% or 100% inspiratory oxygen concentration at the end of anaesthesia. Patients are randomized to either the control group or the intervention group.
The randomization scheme is developed by a non-blinded statistician using the Statistical Analysis Software (SAS) and uploaded to the Research Electronic Data Capture (REDCap) randomization module, enabling delegated team members to generate sequential allocations for enrolled subjects.
Screening of potential study subjects is performed by the PI. The patient is asked to participate in the study by the PI or co-investigator and the study design and procedures are explained to the patient, while they are still in the holding area on the day of the procedure.
The patients in both groups (control and intervention) are equipped with the EIT belt as well as an additional SpO₂ recording device before induction and intubation. After onset of mechanical ventilation as per institutional standards, an inspiratory oxygen concentration of 50% is aimed. Actual oxygen concentration as well as any administration of drugs remain at the discretion of the anesthesia care provider. At the end of the procedure, before the initiation of volatile anesthetic washout, fresh gas flow is increased to 15 liters per minute (or the highest fresh gas flow allowed at the respective anesthesia machine if 15 liters per minute cannot be achieved), and a fraction of inspired oxygen (FiO₂) of either 70% (intervention group) or 100% (control group) for the first 24 randomized patients, and of either 40% (intervention group) or 100% for the subsequent 24 randomized patients is applied.
EIT measurements take place at 6 designated time points before, during and after the procedure. These time points are: Pre-induction, after intubation, just before washout, pre-extubation, one minute after extubation and 60 minutes after extubation in the PACU.
The primary outcome for the study is the Center of Ventilation (CoV), measured through electrical impedance tomography (EIT) compared at one minute after extubation between the control group and intervention groups.
Secondary outcomes include the homogeneity index, and the distribution of lung aeration measured by EIT. In addition, we measure the peripheral oxygen concentration during the whole interventional period and during the PACU stay to evaluate any occurrence of desaturation (SpO₂ <90%) within the first 60 minutes after extubation in the PACU. The incidence of re-intubation or the need for non-invasive ventilation in the next 7 days and an unplanned admission, to either ICU, Intermediate Care Unit (IMC) or the normal ward, as well as the length of stay in the PACU are other clinical secondary outcomes compared between the groups. Subsequent analyses will assess differences between the 70% and 40% oxygen subgroups within the intervention arm to evaluate potential dose-dependency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a single blinded, randomized, trial comparing two study groups ("intervention" and "control")
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Ventilating the patient with 100% oxygen concentration during the wash out phase, before extubation |
| Intervention group | Active comparator | Procedure: Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubationVentilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation |
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
- Elective surgery with general anesthesia and endotracheal intubation
- Expected duration of surgery 1-5 hours
- Consent obtained from patient
Key exclusion criteria (9 listed)
- Patients with inability to give written informed consent
- American Society of Anesthesiologists (ASA) physical status> IV
- Morbid obesity BMI > 40
- Suspected pregnancy and lactation
- Cardiac or thoracic surgery
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 |
|---|---|---|
| Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubationThe investigated intervention is the application of 70% inspired oxygen compared to 100% inspired oxygen during the anesthetic washout, right before extubation of the patient for the first 24 enrolled patients, and 40% inspired oxygen compared to 100% inspired oxygen for the subsequently enrolled 24 patients. Before and after the intervention EIT measurements are performed at designated time points to assess lung aeration and calculate the center of ventilation. This information allows assumptions on atelectasis formation in the patients' lung. | Procedure or surgery | Intervention group |
Primary outcome
The shift of Center of Ventilation (CoV), measured through Electrical Impedance Tomography (EIT) in %.
Time frame: The CoV is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU. The primary outcome is the difference between pre-induction and 1 min post-extubation.
The Center of Ventilation (CoV) is a variable based on the EIT. It is calculated after the initial measurements and defines the most ventilated area of the lung. Assumptions on atelectasis formation can be drawn when the CoV shifts to more ventral areas than measured before. Primary outcome is the absolute difference between the first measurement (before induction) and the measurement directly after extubation in %.
6 secondary outcomes
The 1st secondary outcome is the variation of the inhomogeneity index within each patient, measured through Electrical Impedance Tomography (EIT).
Time frame: The inhomogeneity index is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU.
The 2nd secondary outcome is the distribution of lung aeration, measured through Electrical Impedance Tomography (EIT).
Time frame: The distribution of lung aeration is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU.
Minutes of hypoxemia in the first 60 minutes after extubation
Time frame: The SpO2 data analysis starts with the time the patient enters the PACU and is continued until the patient is discharged from the PACU, which is typically one to two hours after the end of surgery.
Re-intubation or the need for unplanned non-invasive ventilation within 7 days.
Time frame: 7 days post-operative
Unplanned admission to either ICU, IMC or a normal unit.
Time frame: Unplanned admission to either ICU, ICM or a normal unit after the PACU stay is determined in the time frame after end of surgery and up to 7 days after the surgery.
Length of stay in the PACU
Time frame: The length of stay in the PACU is measured in minutes from admission to discharge from the PACU.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Results publication: PubMed 34902800Riva T, Pascolo F, Huber M, Theiler L, Greif R, Disma N, Fuchs A, Berger-Estilita J, Riedel T. Evaluation of atelectasis using electrical impedance tomography during procedural deep sedation for MRI in small children: A prospective observational trial. J Clin Anesth. 2022 May;77:110626. doi: 10.1016/j.jclinane.2021.110626. Epub 2021 Dec 10.
- Results publication: PubMed 25018668Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186/1471-2253-14-51. eCollection 2014.
- Results publication: PubMed 14693669Victorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23.
- Results publication: PubMed 12456458Benoit Z, Wicky S, Fischer JF, Frascarolo P, Chapuis C, Spahn DR, Magnusson L. The effect of increased FIO(2) before tracheal extubation on postoperative atelectasis. Anesth Analg. 2002 Dec;95(6):1777-81, table of contents. doi: 10.1097/00000539-200212000-00058.
- Results publication: PubMed 7760608Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3.
- Results publication: PubMed 8795314Reber A, Engberg G, Wegenius G, Hedenstierna G. Lung aeration. The effect of pre-oxygenation and hyperoxygenation during total intravenous anaesthesia. Anaesthesia. 1996 Aug;51(8):733-7. doi: 10.1111/j.1365-2044.1996.tb07885.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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilating the patient with lower (40 or 70%) oxygen concentration during the wash out phase, before extubation in people with Atelectasis, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 9 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: finished, as of the sponsor's last update on 25 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The shift of Center of Ventilation (CoV), measured through Electrical Impedance Tomography (EIT) in %. (time frame: The CoV is measured at six points: pre-induction, post-intubation, pre-washout, pre-extubation, 1 min post-extubation, and 60 min post-extubation in the PACU. The primary outcome is the difference between pre-induction and 1 min post-extubation.). 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 NCT06538740, which also lists 7 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 25 Sep 2025.