Robotic Surgery
Conditions
Keywords
Electric Impedance Tomography (EIT), High-flow nasal oxygenation, Perioperative oxygenation, Robotic surgery
Brief summary
The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia until discharge from the post-anesthesia care unit in patients undergoing robotic-assisted surgery reduces perioperative oxygen desaturation and postoperative pulmonary complications.
Detailed description
The investigators hypothesize that perioperative HFNO reduces perioperative oxygen desaturation and reduces postoperative pulmonary complications in patients undergoing robotic-assisted surgery.
Interventions
DEVICEHigh flow nasal oxygen
In the intervention group, high-flow nasal oxygen (HFNO) will be initiated at the start of preoxygenation and maintained throughout the apneic phase of induction until successful tracheal intubation. HFNO will be reinitiated immediately prior to extubation and continued throughout the early postoperative period until discharge from the post-anesthesia care unit (PACU). HFNO can be discontinued earlier in the PACU at the discretion of the nurse treating the patient, or upon patient request. HFNO can further be changed to standard of care (standard oxygen mask or standard nasal cannula) at any time at the discretion of the anesthesia provider or PACU nurse. Flow rates and fraction of inspired oxygen (FiO₂) will follow the study protocol (60 liters per minute at 100% O2 for induction of anesthesia, 60 liters per minute at 70% O2 for extubation until 10 minutes after arrival in the PACU with subsequent weaning over the first hour after PACU arrival).
Sponsors
Beth Israel Deaconess Medical Center
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 * Undergoing non-emergent, non-cardiac, intra-abdominal, intra-thoracic 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 * Preoperative intubation or tracheostomy * Anatomical or clinical conditions precluding the use of high-flow nasal oxygen (severe midface trauma, recent nasal surgery, severe nasal septum deviation, severe nasal deformation) * Contraindications to electrical impedance tomography (EIT), including inability to place the EIT belt or presence of active implantable electronic devices (e.g., pacemaker or implantable cardioverter-defibrillator) * Planned postoperative admission to the intensive care unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative oxygen desaturation | Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery | Occurrence of desaturation between induction of anesthesia and discharge from PACU, measured as SpO2 \<92% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End expiratory lung volume (EELV) | Assessed at predefined perioperative time points from pre-oxygenation until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery. | End expiratory lung volume (EELV), measured as difference between pre-oxygenation to post-induction (5min after intubation) and pre-extubation to post-extubation, and pre-extubation to PACU. EELV will be assessed using electrical impedance tomography. |
| Time-weighted average of oxygen saturation | Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery. | Time-weighted average of peripherally measured oxygen saturation, during induction of anesthesia (until intubation), between extubation and arrival in the PACU, and during PACU stay. |
| Postoperative pulmonary complications | From induction of anesthesia up to postoperative day 3 | Postoperative pulmonary complications, defined as re-intubation, emergency non-invasive ventilation, pleural effusion or pneumonia |
Countries
United States
Contacts
CONTACTArian Karimitar, PhD
CONTACTMaximilian S. Schaefer, MD PhD
Outcome results
None listed