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

NCT01869673 | Completed Phase 4

• 1 other identifier: ORALMASK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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'.

Conditions

Nasal Septum Deviation

Keywords

Difficult mask ventilation; extubation; nasal surgery

Outcome Measures

Primary Outcomes (1)

• Tidal volume

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

  5 min after extubation

Secondary Outcomes (1)

• Mask ventilation grade of the patients as Grade0, grade 1, Grade 2, grade 3, grade 4

  5 min after extubation

Other Outcomes (2)

• Ppeak

  5 m extubationin after

• Pmean

  5 min after extubation

Study Arms (2)

Face Mask

ACTIVE COMPARATOR

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

Device: Face Mask

Oral Mask

EXPERIMENTAL

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

Device: Oral Mask

Interventions

Face Mask DEVICE

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

Also known as: Adult anesthesia face mask, Rusch reusable anatomical black rubber adult face mask

Face Mask

Oral Mask DEVICE

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

Also known as: Pediatric anesthesia face mask, Rusch reusable anatomical black rubber pediatric mask

Oral Mask

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (2)

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Location

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Salem MR, Ovassapian A. Difficult mask ventilation: what needs improvement? Anesth Analg. 2009 Dec;109(6):1720-2. doi: 10.1213/ANE.0b013e3181be0541. No abstract available.

  PMID: 19923495 BACKGROUND

• Joffe AM, Hetzel S, Liew EC. A two-handed jaw-thrust technique is superior to the one-handed "EC-clamp" technique for mask ventilation in the apneic unconscious person. Anesthesiology. 2010 Oct;113(4):873-9. doi: 10.1097/ALN.0b013e3181ec6414.

  PMID: 20808210 BACKGROUND

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Murat Sayın, Ass Prof

  Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2013-05

Locations

TU (2)