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Trial · NCT07912619

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOropharyngeal Leak Pressure (OLP)Measured immediately after device placementOropharyngeal leak pressure measured immediately after airway device placement, reflecting the sealing performance of the supraglottic airway.
SecondaryFirst-Attempt Success RateDuring device insertion (intraoperative)Proportion of participants in whom the airway device was successfully placed on the first insertion attempt.
SecondaryNumber of Insertion AttemptsDuring device insertion (intraoperative)Total number of attempts required to successfully place the airway device.
SecondaryGlottic Exposure Grade (Video LMA group)During device insertion (intraoperative)Grade of glottic view (Grade 1-4) assessed via camera image in the video laryngeal mask group.
SecondaryHeart RateBefore induction (T0), after device placement (T1), and during surgery (T2)Heart rate (beats per minute) recorded before induction, after device placement, and during surgery.
SecondarySystolic Blood PressureBefore induction (T0), after device placement (T1), and during surgery (T2)Systolic blood pressure (mmHg) recorded before induction, after device placement, and during surgery.
SecondaryDiastolic Blood PressureBefore induction (T0), after device placement (T1), and during surgery (T2)Diastolic blood pressure (mmHg) recorded before induction, after device placement, and during surgery.
SecondaryPeripheral Oxygen Saturation (SpO2)Before induction (T0), after device placement (T1), and during surgery (T2)Peripheral oxygen saturation (%) recorded before induction, after device placement, and during surgery.
SecondaryIntraoperative ComplicationsIntraoperative periodIncidence of laryngospasm, bronchospasm, desaturation (SpO2 \<90%), need for device repositioning, and need for conversion to endotracheal intubation.
SecondaryPostoperative Sore Throat, Hoarseness, and Nausea/VomitingPostoperative hour 1 (T3) and hour 6 (T4)Presence or absence of sore throat, hoarseness, and nausea/vomiting assessed at 1 and 6 hours postoperatively.
OtherDevice Insertion TimeDuring device insertion (intraoperative)Time (in seconds) required to successfully insert the airway device.
OtherInspired and Expired Tidal VolumeDuring surgery (T2)Inspired and expired tidal volume (mL) recorded during surgery.
OtherMinute Ventilation Leak RateDuring surgery (T2)Minute ventilation leak rate (%) recorded during surgery.
OtherPeak Airway PressureDuring surgery (T2)Peak airway pressure (cmH2O) recorded during surgery.
OtherBlood on Device After RemovalAt the end of surgery, upon device removalPresence or absence of visible blood on the airway device following its removal.
OtherInduction-to-Incision Time, Total Anesthesia Duration, and Recovery TimeThroughout the perioperative periodTime from anesthesia induction to surgical incision, total duration of anesthesia, and time to recovery, all recorded in minutes.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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