General Anesthesia Clinical Trial
Official title:
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.
NCT number | NCT05291117 |
Other study ID # | 4631 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | May 1, 2022 |
Verified date | April 2022 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - ASA I-II. Exclusion Criteria: - BMI > 30, - pregnancy, - cardiac arrhythmia, - high risk of aspiration, - neuromuscular disease, - patient refusal. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Policlinico Agostino Gemelli | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of tCO2 during THRIVE ventilation. | CO2 values (reported as mmHg) measured by Radiometer monitor. | pre-anesthesia; up to 1 hour. | |
Primary | change of SpO2 during THRIVE ventilation. | SpO2 values (reported as "%") measured by oxymeter. | pre-anesthesia; up to 1 hour. | |
Secondary | Airway related complications. | Incidence of patients requiring airway manipulations (nasal cannula, manual ventilation, laryngeal mask ventilation, tracheal intubation) by the anesthesiologist, reported as "% of total number of patients". | 2 hours after the end of anesthesia. | |
Secondary | Postoperative complications - 1 | Incidence of patients suffering from cough, sore throat, dysphagia, dysphonia, laryngospasm, oxygen desaturation (defined as SpO2<94%), reported as "% of total number of patients" | 2 hours after the end of anesthesia. | |
Secondary | Postoperative complications - 2 | Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea). | 2 hours after the end of anesthesia. | |
Secondary | Postoperative complications - 3 | Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort). | 2 hours after the end of anesthesia. |
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