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Robotic SurgeryVIOLETNCT07277244

Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study

A study testing Low Intensity Mechanical Ventilation in people with Robotic Surgery and Post Operative Pulmonary Complications, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low Intensity Mechanical Ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
8 Apr 2026to 23 Sep 2026
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

  • Adult patients undergoing non-emergent intra-abdominal or pelvic robot-assisted surgery with an expected duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure

Who cannot join

  • Known pregnancy
  • Pre-existing intubation or tracheostomy
  • Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery
  • Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

Other trials in United States

About this study

The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.

Read the detailed description

The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.

Being tested
Low Intensity Mechanical Ventilation
Keywords
Lung protective ventilation, Electric Impedance Tomography (EIT)

What participants receive

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

  • Low Intensity Mechanical VentilationDevice

    A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure:

    1. Recruitment maneuver
    2. Tidal volume set to 8 ml/kg predicted body weight (PBW) and stepwise adjustment to achieve a driving pressure (Plateau pressure - PEEP) < 13 cmH2O with a minimum tidal volume of 5ml/kg PBW
    3. Respiratory rate adjustment to maintain a target end-tidal carbon dioxide concentration (etCO₂) between 45 and 55 mmHg.
    4. Reassessment and adaptation after Trendelenburg positioning and pneumoperitoneum.
    5. Re-adjustment of Tidal Volume and PEEP ventilator settings to (2.) after exsufflation and return to the supine position. FiO₂ set to 70% during the washout phase of the inhalational anesthetic until extubation.
Study groups in NCT07277244
Study groupRoleWhat they receive
ControlNo interventionA guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis.
InterventionExperimentalA bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings.
Receives: Device: Low Intensity Mechanical Ventilation

What is being measured

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

  1. ΔEELV between baseline and after extubation before leaving the operating room.

    Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room.

    Measured: Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).

Secondary outcomes (15)

  1. Proportion of patients with postoperative pulmonary complications at day 7

    Re-intubation, hypoxemia requiring oxygen therapy, pleural effusion, pneumonia, atelectasis or emergency non-invasive ventilation

    Measured: This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery

  2. Recruitment rate

    Proportion of patients enrolled in the study-defined as those who provided acceptance and signed informed consent-relative to all patients approached.

    Measured: Day 0

  3. Intervention deliverability

    proportion of patients in the intervention arm in whom the full bundle of protective low-intensity ventilation strategies is delivered as planned across all predefined intraoperative phases.

    Measured: From intubation to extubation at Day 0

  4. EELV

    End-expiratory lung volume measured by Electrical Impedance Tomography in mL

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

  5. COV

    Center of ventilation measured by Electrical Impedance Tomography in percentage

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

  6. RVDI

    Regional ventilation delay inhomogeneity measured by Electrical Impedance Tomography (unitless)

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

  7. GI

    Global inhomogeneity index measured by Electrical Impedance Tomography (unitless)

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

  8. Dorsal ROI

    Maximum dorsal ratio of impedance measured by Electrical Impedance Tomography (unitless)

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation, after PACU admission and 60min after PACU admission

  9. EEPL

    End-expiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)

    Measured: Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation

  10. EIPL

    End-inspiratory transpulmonary pressure, calculated as airway pressure minus esophageal pressure (cmH₂O)

    Measured: Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation

  11. Relationship between body mass index with optimal PEEP

    Correlation between BMI (kg/m²) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.

    Measured: Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

  12. Relationship of the degree of Trendelenburg inclination with optimal PEEP

    Correlation between the degree of Trendelenburg inclination (in degree) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.

    Measured: Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

  13. Relationship of the pneumoperitoneum (insufflation) with optimal PEEP

    Correlation between the pneumoperitoneum (insufflation in cmH2O) and the optimal positive end-expiratory pressure (PEEP, cmH₂O) determined after pneumoperitoneum insufflation and patient positioning for surgery.

    Measured: Intraoperative Day 0: after insufflation of pneumoperitoneum and positioning the patient for surgery

  14. Intraoperative oxygenation

    Intraoperative peripheral pulsed oxygen saturation (SpO2)

    Measured: Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation, after extubation

  15. Postoperative oxygenation

    Postoperative peripheral pulsed oxygen saturation (SpO2)

    Measured: Postoperative Day 0: after PACU admission and 60min after PACU admission

Timeline

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

  1. First posted11 Dec 2025
  2. Study start8 Apr 2026
  3. Primary completion16 Sep 2026
  4. Study completion23 Sep 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07277244
Sponsor's protocol ID
2025P000986
Acronym
VIOLET
Status last verified
Oct 2026
First submitted
20 Nov 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13.

    PubMed 29793604

  • Schaefer 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 25018668

Questions about this trial

What is this clinical trial studying?

A study testing Low Intensity Mechanical Ventilation in people with Robotic Surgery and Post Operative Pulmonary Complications, 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 1 inclusion and 4 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 6 Oct 2026. 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?

ΔEELV between baseline and after extubation before leaving the operating room. (time frame: Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).). 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 NCT07277244, which also lists 2 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 6 Oct 2026.

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