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Enrolling by invitation NCT07277244

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

No phase Interventional Robotic Surgery Post Operative Pulmonary Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low Intensity Mechanical Ventilation.
Who it may be relevant to
Registry conditions: Robotic Surgery, Post Operative Pulmonary Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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

Interventions

  • Device Low Intensity Mechanical Ventilation
    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 Trendelen

Primary outcome measures

  • 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).]
Secondary outcome measures (12)
  • Proportion of patients with postoperative pulmonary complications at day 7 [Time frame: This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery]
  • Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram [Time frame: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
  • Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram [Time frame: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
  • Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram [Time frame: Perioperative Day 0: before anesthesia and after PEEP/TV/RR titration]
  • Recruitment rate [Time frame: Day 0]
  • Intervention deliverability [Time frame: From intubation to extubation at Day 0]
  • EELV [Time frame: 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]
  • COV [Time frame: 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]
  • RVDI [Time frame: 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]
  • GI [Time frame: 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]
  • Dorsal ROI [Time frame: 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]
  • EEPL [Time frame: Perioperative Day 0: after intubation, after PEEP/TV/RR titration, after insufflation and positioning, after PEEP/TV/RR reassessment, just before extubation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

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. PMID 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. PMID 25018668

Identifiers

NCT: NCT07277244 · 2025P000986

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗