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THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05291117
Recruitment Status : Completed
First Posted : March 22, 2022
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.


Condition or disease
Oxygen General Anesthesia Hysteroscopy

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.
Actual Study Start Date : February 1, 2022
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : May 1, 2022



Primary Outcome Measures :
  1. change of tCO2 during THRIVE ventilation. [ Time Frame: pre-anesthesia; up to 1 hour. ]
    CO2 values (reported as mmHg) measured by Radiometer monitor.

  2. change of SpO2 during THRIVE ventilation. [ Time Frame: pre-anesthesia; up to 1 hour. ]
    SpO2 values (reported as "%") measured by oxymeter.


Secondary Outcome Measures :
  1. Airway related complications. [ Time Frame: 2 hours after the end of anesthesia. ]
    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. Postoperative complications - 1 [ Time Frame: 2 hours after the end of anesthesia. ]
    Incidence of patients suffering from cough, sore throat, dysphagia, dysphonia, laryngospasm, oxygen desaturation (defined as SpO2<94%), reported as "% of total number of patients"

  3. Postoperative complications - 2 [ Time Frame: 2 hours after the end of anesthesia. ]
    Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea).

  4. Postoperative complications - 3 [ Time Frame: 2 hours after the end of anesthesia. ]
    Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients undergoing operative hysteroscopy
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women scheduled for elective operative hysteroscopies will be included.
Criteria

Inclusion Criteria:

  • ASA I-II.

Exclusion Criteria:

  • BMI > 30,
  • pregnancy,
  • cardiac arrhythmia,
  • high risk of aspiration,
  • neuromuscular disease,
  • patient refusal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05291117


Locations
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Italy
IRCCS Policlinico Agostino Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Publications of Results:

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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05291117    
Other Study ID Numbers: 4631
First Posted: March 22, 2022    Key Record Dates
Last Update Posted: May 25, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Transnasal humified high flow oxygen