이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

THRIVE Ventilation for Operative Hysteroscopy Under General Anesthesia

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Apnoeic Ventilation During Operative Hysteroscopic Procedures Under General Anesthesia: an Observational Study.

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.

연구 개요

상태

완전한

상세 설명

Background Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE), term coined by Patel and Nouraei, refers to a technique that allows to extend the apnoeic window in patients undergoing general anesthesia by delivering 100% of heated and humidified oxygen at 70L/min using the Optiflow THRIVE-TM system (Fisher and Paykel Healthcare Ltd, Auckland, New Zealand), in order to maintain viable gas exchange during an extended period of cessation of muscular activity.

Apnoeic oxygenation is a physiological phenomenon in which oxygen flow into the lungs is driven by a negative pressure gradient generated by the difference between the alveolar rates of oxygen absorption and carbon dioxide excretion.

Potentially rapid and dangerous rise in carbon dioxide concentration is prevented by the underlying mechanisms occurring during high-flow nasal oxygenation under apnoeic conditions.

As proposed by Slutsky and more recently by Hermez, cardiogenic oscillations (changes in airway gas flow and pressure synchronous with the cardiac cycle) and their interactions with supraglottic turbulence generated by high-flow nasal oxygenation might be the underlying mechanisms of THRIVE and of the enhanced clearance of carbon dioxide.

Many clinically relevant benefits have been associated with nasal high flow. It provides a constant FiO2 by delivering the gas at flow rates that exceed the patient's peak inspiratory flow rate. It is effective in providing a flow-dependent effect of continuous positive airway pressure of about 1 cmH20 for every 10 L/min increase in gas flow within a range of 30-50 L/min, up to 11.9 cm H20 at a maximum flow of 100 L/min. Moreover, it reduces respiratory rate, it clears in a dose-dependent manner dead space of the upper airways and possibly even below the soft palate, leading to a reduction in rebreathing of expired air, with the potential to increase the alveolar volume and to improve alveolar ventilation and gas exchange. It is likely that, especially in patients with mild to moderate respiratory failure, enhanced comfort from heated humidification and flushing of dead space, lessen the work of breathing, thus improving thoraco-abdominal synchrony. By contrast, in spontaneously breathing patients, as a consequence of the large amount of air inflated into the stomach, higher number of reflux events could be detected increasing the risks of aspiration.

This technique has been successfully applied in several clinical settings to extend the apnoeic window after the induction of general anesthesia and during laryngoscopy in predicted difficult airway management. As long as airway patency was present, it succeeded in extending the apnoeic window up to 65 minutes. PaO2 and peripheral oxygen saturation remained stable and the rate of rise of CO2 during apnoea was reduced from earlier findings of 0.5 kPa/min with conventional low-flow systems to 0.15 kPa/min.

THRIVE has also been used as unique airway management technique for procedural sedation or when general anesthesia was performed for brief surgical procedures: it was able to keep patients with mild systemic disease well oxygenated, maintaining PaO2 stable with decreased rates of rise of CO2 during apnoea, as compared to conventional low-flow systems for oxygen therapy, such as the Venturi mask.

Operative hysteroscopy is a brief surgical procedure (< 30 minutes), usually performed in a day-surgery regimen. Typical anesthesiologic management in this setting includes general anesthesia with intravenous agents (propofol plus fentanyl) and positive pressure ventilation through laryngeal mask (I-gel). The application of THRIVE in this setting has potential advantages either for the patient, including minimal airway manipulation and greater comfort, either for the anesthesia provider, facilitating procedural technique and airway management.

Aim of the study The aim of this study is to investigate the effects of THRIVE apnoeic ventilation during operative hysteroscopy under general anesthesia.

Monitoring Standard perioperative monitoring will include non-invasive blood pressure (NIBP) with an upper arm cuff, 3-lead ECG, peripheral oxygen saturation (SpO2) and bispectral index (BIS). NIBP will be measured every 5 minutes before induction of anesthesia and throughout the procedure. Transcutaneous carbon dioxide (tcCO2) will be continuously monitored by Radiometer TCM5 monitor.

Study protocol Upon arrival on the operating theatre, each patient will be placed in supine position in lithotomic position; a peripheral venous cannula will be inserted on the hand or forearm and 500 ml Ringer-Lactate solution infusion will be started. Omeprazole 40 mg and dexametasone 4 mg will be given preoperatively. 3 minutes of pre-oxygenation will be performed with 100% oxygen 30 L/min delivered via dedicated Optiflow THRIVE-TM nasal cannulae. General anesthesia will then be induced with target-controlled infusion (TCI) of propofol (7 mcg/kg) through Orchestra Infusion system (Fresenius Kabi) plus fentanyl (1,5 mcg/kg). The range of maintenance of propofol concentration will be 4-6 mcg/ml, titrated to maintain a level of anesthesia monitored by BIS between 40 and 50. With the onset of general anesthesia oxygen flow will be increased to 70 L/min and maintained throughout the procedure. Head repositioning, jaw thrust, oropharyngeal cannula placement could be used to improve airway patency during the procedure. In case of episodes of oxygen desaturation, defined as SpO2<94%, or rise of tcCO2 over 45 mmHg, positive pressure ventilation by facial mask or laryngeal mask will be applied by the practitioner based on clinical judgement.

At the end of the procedure, propofol will be stopped. Paracetamol 1g, ondansetron 4 mg and ketorolac 30 mg will be administered as routine clinical practice.

The awake patient will be moved to the PACU for three hours of post-operative monitoring as required by internal practice for day-surgery procedures. Standard monitoring will include NIBP measured every 15 minutes, 3-lead ECG, and peripheral oxygen saturation (SpO2).

One hour after the end of the procedure and before discharge from the PACU the patient will be asked to rate its perceived degree of dyspnoea with the Borg dyspnoea score and its degree of comfort by Visual Numerical Scale (VAS).

In case of episodes of oxygen desaturation, defined as SpO2<94%, supplemental oxygen will be initially provided to the patient by low-flow Venturi mask with FiO2 40%.

Discharge from the PACU will require an Aldrete score of 9-10.

Sample size calculation For this pilot study no sample size calculation was performed.

연구 유형

관찰

등록 (실제)

30

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Rome, 이탈리아, 00168
        • IRCCS Policlinico Agostino Gemelli

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

Women scheduled for elective operative hysteroscopies will be included.

설명

Inclusion Criteria:

  • ASA I-II.

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 전용
  • 시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
change of tCO2 during THRIVE ventilation.
기간: pre-anesthesia; up to 1 hour.
CO2 values (reported as mmHg) measured by Radiometer monitor.
pre-anesthesia; up to 1 hour.
change of SpO2 during THRIVE ventilation.
기간: pre-anesthesia; up to 1 hour.
SpO2 values (reported as "%") measured by oxymeter.
pre-anesthesia; up to 1 hour.

2차 결과 측정

결과 측정
측정값 설명
기간
Airway related complications.
기간: 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 hours after the end of anesthesia.
Postoperative complications - 1
기간: 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"
2 hours after the end of anesthesia.
Postoperative complications - 2
기간: 2 hours after the end of anesthesia.
Incidence of dyspnoea (measured with Borg dyspnoea score: 0= no dyspnoea, 10= maximal dyspnoea).
2 hours after the end of anesthesia.
Postoperative complications - 3
기간: 2 hours after the end of anesthesia.
Incidence of discomfort (measured with Visual Analogue Scale: 0= no discomfort, 10= maximal discomfort).
2 hours after the end of anesthesia.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 2월 1일

기본 완료 (실제)

2022년 4월 1일

연구 완료 (실제)

2022년 5월 1일

연구 등록 날짜

최초 제출

2022년 1월 19일

QC 기준을 충족하는 최초 제출

2022년 3월 21일

처음 게시됨 (실제)

2022년 3월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 5월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 5월 24일

마지막으로 확인됨

2022년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 4631

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
구독하다