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临床试验/NCT04395248
NCT04395248已完成4 期

An Investigation of Optimal Anesthesia for Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Occurrence of difficult laryngoscopy

研究概览

简要总结

Obese patients have a higher risk of anesthesia compared to the non-obese, including difficult intubation, rapid desaturation, difficult vascular access, and delayed recovery from anesthesia. This study aims to investigate the optimal anesthesia strategy for morbidly obese patients undergoing bariatric surgery in airway management, preoxygenation, arterial cannulation, and type of volatile anesthetic with M-Entropy guidance. The investigators will conduct a two-year clinical trial using permuted block randomization to evaluate multiple outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG) at Shuang Ho Hospital, Taipei Medical University. Particularly, the investigators will explore the role of ultrasound, an easily accessible modality for anesthesiologists, in examining upper airway anatomy and guiding arterial cannulation. The investigators will also assess the effectiveness of high-flow nasal cannula as a preoxygenation tool in preventing desaturation.

详细描述

The investigators will conduct a clinical trial using permuted block randomization and conforming to the CONSORT Statement to investigate multiple clinical outcomes in obese patients undergoing LSG at Shuang Ho Hospital, Taipei Medical University, New Taipei City, Taiwan. Three randomizations will be conducted, including radial artery catheterization using ultrasound guidance or blind palpitation, preoxygenation using HFNC or CPAP, and volatile anesthesia with desflurane or sevoflurane with or without M-Entropy guidance. A computer-generated list of randomizations (Research Randomizer, www.randomizer.org) will be used for these group allocations.

  1. Exploring potential risk factors of difficult intubation using ultrasound: A prospective single-blind cohort study

Before surgery, all enrolled patients will be examined for appearance features regarding difficult airway, including interincisor distance (< 3 cm or not), mentohyoid distance, thyromental distance (< 6.5 cm or not), neck movement (< 80 degrees or not), neck circumference measured at the thyroid cartilage (> 43 cm or not), modified Mallampati score, upper lip bite test, and mandibular prognathism test. Besides, ultrasound will be used to assess upper airway anatomy, including pretracheal soft tissue depth27 and height and width of tongue base. Regarding pretracheal soft tissue depth, the distance from the skin to the anterior aspect of the trachea will be measured at three levels: vocal cords, thyroid isthmus, and suprasternal notch. The amount of soft tissue at each zone is calculated by averaging the amounts of soft tissue in millimeters obtained in the central axis of the neck and 15 millimeters to the left and right of the central axis.

Moreover, the increased tongue volume and deposition of fat at the base of tongue in obese people has been shown to be highly associated with risk of obstructive sleep apnea. To measure the anatomy of tongue base, with the patient in a seated position, the convex transducer in the frequencies 1.5 to 5.0 MHz (GE C1-5-RS, GE Healthcare, Chicago, IL, USA) of a portable ultrasound device (LOGIQTM, GE Healthcare, Chicago, IL, USA) will be introduced to the skin of the neck in the submental region coronally, immediately cephalad to the body of the hyoid bone, and then in the area between the hyoid bone and the symphysis of the mandible. The patients will be instructed to avoid tongue movements, swallowing, or talking. Maximal width of tongue base, tongue base height, and maximal height of mid-tongue will be measured. The same anesthesiologist will perform all ultrasound measurements before surgery. Upon arrival at operating room, patients will be initially placed in a ramped position and then moved into a reverse Trendelenburg position to achieve a 30-degree incline of the thorax before preoxygenation.

After induction of anesthesia, another anesthesiologist, blinded to all preoperative evaluation, will perform all laryngoscopies in this study. The laryngoscopy intubation will be performed using a size-3 or -4 Macintosh (Rüsch Inc., Duluth, GA, USA) blade and a styletted endotracheal tube. The laryngoscopic view will be graded according to Cormack and Lehane's classification with external laryngeal pressure applied.59 Laryngoscopy views graded as III or IV are defined as difficult. In case of failed direct laryngoscopy despite external laryngeal manipulation in the first attempt, video-assisted laryngoscope GlideScope® (Verathon Medical, Bothell, WA, USA) will be used as an intubation rescue technique. The video-assisted laryngoscope will be kept on standby at the operating room before induction. The correct placement of the endotracheal tube will be confirmed by capnography. 2. Radial artery catheterization using ultrasound guidance or blind palpation: An open-label randomized controlled trial

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 to 65 years
  • BMI ≥ 30 kg/m2
  • Undergoing laparoscopic sleeve gastrectomy at Shuang-Ho Hospital, Taiwan

排除标准

  • Severe cardiopulmonary disease
  • Psychiatric disorder
  • History of head and neck surgery or radiation therapy
  • Cervical spine injury
  • Renal insufficiency (estimated creatinine clearance < 60 ml/min)
  • SpO2 < 90% in room air
  • Hemodynamic instability
  • Preexisting arterial catheterization during the same visit within 7 days
  • Patient refusal

研究组 & 干预措施

Risk factors of difficult intubation

Active Comparator

Appearance anpalpationpalpationpalpationd ultrasound features for predicting difficult laryngoscopy intubation

干预措施: Exploring potential risk factors of difficult intubation using ultrasound (Procedure)

Radial artery cannulation using ultrasound or blind palpation

Active Comparator

In the ultrasound group, a linear vascular probe in the frequencies 5 to 13 MHz (GE 12L-RS, GE Healthcare, Chicago, IL, USA) of portable ultrasound device (LOGIQTM, GE Healthcare, Chicago, IL, USA) will be applied to the skin to localize the radial artery and a 20-gauge catheter will be inserted distal to the transducer and directed according to the ultrasound image.

干预措施: Radial artery catheterization using ultrasound guidance or blind palpation (Procedure)

Preoxygenation using high-flow nasal cannula or facemask

Active Comparator

In the HFNC group, preoxygenation will be performed using HFNC (Optiflow™, Fisher & Paykel Healthcare, Auckland, NZ), nasal prongs set at 30 L/min flow of heated and humidified 100% oxygen. In the facemask group, patients will breath spontaneously with an anesthetic facemask and 100% oxygen 15 L/min. Gas flow for HFNC or facemask can be adjusted depending on patients' tolerance. During laryngoscopy intubation, HFNC will be left in place with the nasal flow escalated to 50 L/min of 100% oxygen in order to achieve apneic oxygenation. In the facemask group, the facemask will be removed when apnea occurs.

干预措施: Comparing the effectiveness of preoxygenation between high-flow nasal cannula and facemask (Device)

Type of volatile anesthetics and M-Entropy guidance

Active Comparator

Patients will be randomized by a computer-generated list into one of the four groups, desflurane with usual care (N=20), desflurane with M-Entropy guidance (N=20), sevoflurane with usual care (N=20), and sevoflurane with M-Entropy guidance (N=20).

干预措施: Type of volatile anesthetics and M-Entropy guidance of anesthesia depth (Drug)

结局指标

主要结局

Occurrence of difficult laryngoscopy

时间窗: One day before surgery to tracheal intubation

The laryngoscopic view will be graded according to Cormack and Lehane's classification with external laryngeal pressure applied. Grade 1: Most of the glottis is visible; Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen; Grade 3: Only the epiglottis is visible; Grade 4: No laryngeal structures are visible.

First-attempt success rate for arterial cannulation

时间窗: Before induction of anesthesia

An attempt is defined as a new penetration of the skin with the needle, followed by an unlimited number of subcutaneous needle redirections.

PaO2 after preoxygenation

时间窗: Before induction of anesthesia

Arterial blood gas will be analyzed promptly after 5-min preoxygenation.

Time to spontaneous eye opening

时间窗: The period from discontinuation of volatile anesthetics to spontaneous eye opening, an average of 15 minutes

The interval from discontinuation of volatile anesthetics to spontaneous eye opening

次要结局

  • Patient comfort levels(Before induction of anesthesia)
  • First-attempt success rate for intubation(After induction of anesthesia)
  • Time to successful intubation(After induction of anesthesia)
  • Time to successful arterial catheterization(Before induction of anesthesia)
  • Number of attempts for arterial cannulation(Before induction of anesthesia)
  • The lowest SpO2 during intubation(After induction of anesthesia)
  • PaCO2 before and after preoxygenation(Before induction of anesthesia)
  • Number of sites and catheters used for arterial cannulation(Before induction of anesthesia)
  • Relevant complications of arterial cannulation(Before induction of anesthesia)
  • SpO2 before and after preoxygenation(Before induction of anesthesia)
  • Desaturation event during intubation(After induction of anesthesia)
  • Time to tracheal extubation(The period from discontinuation of volatile anesthetics to tracheal extubation, an average of 25 minutes)
  • Time to orientation in time and place(The period from discontinuation of volatile anesthetics to orientation in time and place, an average of 20 minutes)
  • Time to leave operating room(The period from discontinuation of volatile anesthetics to leaving operating room, an average of 30 minutes)
  • Event of emergence agitation(During or after tracheal intubation at the end of surgery)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YingHsuanTai

Principal Investigator

Taipei Medical University Shuang Ho Hospital

研究点 (1)

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