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THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

NCT05291117 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-05-25

No results posted yet for this study

Summary

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min in order to maintain viable gas exchange during an extended period of cessation of spontaneous ventilation.

This technique has been successfully applied in several clinical settings (induction of general anesthesia, laryngoscopy in predicted difficult airway management, and as unique airway management technique for procedural sedation or general anesthesia for brief surgical procedures).

Operative hysteroscopy is a brief surgical procedure usually performed under general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through facial or laryngeal mask.

The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during hysteroscopy under general anesthesia. Our primary outcome is to describe the trend of SpO2 and tcCO2 during the procedures.

Secondary outcomes include description of arrhythmias requiring medical treatment, hemodynamic instability, unmanageable copious secretions, airway obstruction or inability to maintain airway patency, witnessed aspiration, airway related complications, number of airway manipulations, adverse events, assessment of postoperative dyspnoea and comfort, patient satisfaction.

Women (\> 18 years old and \< 70 years old), ASA physical status I and II presenting for elective operative hysteroscopies will be included.

A number of 30 patients was planned to target the primary outcome.

Conditions

  • Oxygen
  • General Anesthesia
  • Hysteroscopy

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-04-01
Completion
2022-05-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291117 on ClinicalTrials.gov