跳至主要内容
临床试验/NCT01869673
NCT01869673已完成4 期

A Comparison of the Face Mask and Oral Mask Ventilation After Nasal Surgery.

Diskapi Teaching and Research Hospital4 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2013年6月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
4
主要终点
Tidal volume

研究概览

简要总结

Difficult mask ventilation is usually studied in relation to airway management and difficult intubation and mostly during the induction period of anesthesia.

According to the closed claim reports tracheal extubation and recovery of anesthesia is associated with brain damage or death.

Difficult mask ventilation can also be a problem during the emergence phase of anesthesia after extubation. Especially after nasal surgery the use of nasal tampon and casts can resemble upper airway obstruction and facial deformity and cause difficult mask ventilation.

The effectiveness of ventilation is affected by the design of the mask. Leaks may develop due to the inability to obtain a tight seal.

The use of an oral mask for ventilation in patients with nasal tumors and after rhinoplasty for patients with a nasal cast has been reported. This suggests that oral mask ventilation, rather than face mask ventilation, should be considered after nasal surgery.

The aim of this prospective randomized study is to compare the face mask and oral mask ventilation after nasal surgery in terms of the mask ventilation classification, airway pressure, minute ventilation and tidal volume.

Our hypothesis is that ventilation with oral mask would provide better airway pressures, superior mask-ventilation classification and higher tidal volumes compared to face mask ventilation in patients with obstructed nasal pasage (nasal packing and/or cast) after nasal surgery'.

详细描述

American Society of Anesthesiologists (ASA) physical class I or II, adult patients aging 19-45 yr, scheduled for nasal surgery will be recruited.

Patient characteristics will be recorded; age, gender ASA physical status, height, weight. Simple randomization will be accomplished with a computer-generated sequence of numbers and sealed envelopes will be used to allocate patients into 2 treatment sequences, Sequence O: oral mask ventilation followed by face mask ventilation and Sequence FM: face mask ventilation followed by oral mask ventilation.

Patients will be premedicated with midazolam. Ringer's lactate infusion at 15 mL•kg-1•h-1 will be initiated. Standard monitors will be established including neuromuscular monitorization and the Bispectral index monitor (BIS).

The patients head will be placed in the neutral position on a positioning pad Anesthesia will be induced with propofol 2 ml kg and fentanyl 50 mcg. Anesthesia will be maintained with oxygen in nitrous oxide and sevoflurane. The patient was ventilated trough an face mask. The appropriate size mask with the best fit will be selected and the mask size will be noted. Gas flow will be 4 L min. During the induction period the mask ventilation grade of the patients will be determined (Grade 0: ventilation by mask not attempted, Grade 1: ventilated by mask, Grade 2: ventilated by mask with oral airway or other adjuvant, Grade 3: difficult mask ventilation (inadequate, unstable, or requiring two practitioners), Grade 4: unable to mask ventilate (Han's grading scale)) and patients with Grade ≥ 2 will be excluded from the study. Muscle relaxation and intubation will be facilitated with rocuronium 0.6 mg kg-1. At the end of surgery trachea will be extubated when TOF 0.9 is obtained and the patient is spontaneous breathing, meanwhile inhalation anesthesia will be continued (BIS 50-70). After extubation, spontaneous ventilation will be assisted with mask ventilation. Mask ventilation will be applied according to sequence allocation and the mask ventilation grades with each mask technique will be determined with the same grading system. Spontaneous ventilation will be assisted with mask ventilation.

The face mask will be applied with the one handed EC-clamp technique. The mask will be placed over the bridge of the nose and mouth and a chin-lift, head tilt maneuver will be used. The oral mask; size 1 or 2 child's mask will be placed only over the mouth and the one handed EC-clamp technique with the chin-lift, head tilt maneuver will be used again. The masks will be changed after three consecutive measurements for each mask technique and the crossover time will be short.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical class I or II
  • adult patients
  • ageing 19-45 yr
  • scheduled for nasal surgery

排除标准

  • Respiratory diseases
  • obstructive sleep apnea
  • obesity (body mass index >30 kg m2)
  • difficult intubation-ventilation-airway
  • emergency cases

研究组 & 干预措施

Face Mask

Active Comparator

Patients will be ventilated with a face mask first and with a oral mask thereafter

干预措施: Face Mask (Device)

Oral Mask

Experimental

Patients will be ventilated trough an oral mask first and trough a face mask thereafter

干预措施: Oral Mask (Device)

结局指标

主要结局

Tidal volume

时间窗: 5 min after extubation

assessment will be done after extubation, when the spontaneous respiratory rate is 10 breaths/min.

次要结局

  • Mask ventilation grade of the patients as Grade0, grade 1, Grade 2, grade 3, grade 4(5 min after extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DILEK YAZICIOGLU

Principal Investigator

Diskapi Teaching and Research Hospital

研究点 (4)

Loading locations...

相似试验

A Comparison of the Face Mask and Oral Mask... | 临床试验