Nasal Septum DeviationPhase 4NCT01869673
A Comparison of the Face Mask and Oral Mask Ventilation After Nasal Surgery
A Phase 4 study testing Face Mask and Oral Mask in people with Nasal Septum Deviation, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Nasal Septum Deviation
- What is being tested?
- Face Mask and Oral Mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2013to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical class I or II
- adult patients
- ageing 19-45 yr
- scheduled for nasal surgery
Who cannot join
- Respiratory diseases
- snoring
- smoking
- obstructive sleep apnea
- obesity (body mass index >30 kg m2)
- difficult intubation-ventilation-airway
- emergency cases
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara
About this study
Official title: A Comparison of the Face Mask and Oral Mask Ventilation After Nasal Surgery.
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.
Read more
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'.
Read the detailed description
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.
The respiratory parameters will be measured with the monitor contained in the Drager Primus anesthesia machine. The observer providing mask ventilation is experienced in mask ventilation and will be blinded to the monitor display. All patients will be ventilated by the same observer. Data will be recorded by independent residents. The mask ventilation classification will be recorded. mean airway pressure (Pmean), maximum airway pressure (Ppeak) , tidal volume (TV), expired tidal volume (TVe) minute volume leak (MVleak) and minute volume (MV) will be recorded during spontaneous ventilation. Volatile anesthesia will be ceased after observing that the patients are calm and not coughing and the respiratory measures will be evaluated thereafter. The APL (airway pressure release) valve will be closed during the evaluation of mask ventilation. Sufficient chest movement, mask leak, gastric insufflations will be assessed. Indicators for difficult mask ventilation are defined as; TV< 4 ml kg, inadequate chest movements, the need for an oropharyngeal airway, two handed mask ventilation, need to increase the gas flow, gastric insufflations, need to ventilate with two operators.
It was planned to enroll 30 patients in this study. After performing a pilot study we calculated that 10 patients in each group was sufficient to detect a difference between groups concerning tidal volume with 0.95 power and 0.05 alfa error. We decided to enroll 24 patients in the study due to possible drop outs.
- Conditions
- Nasal Septum Deviation
- Being tested
- Face Mask, Oral Mask
- Keywords
- Difficult mask ventilation, extubation, nasal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face MaskDevice
Also called Adult anesthesia face mask, Rusch reusable anatomical black rubber adult face mask
Patients will be ventilated trough a face mask first and trough a oral mask thereafter
Oral MaskDevice
Also called Pediatric anesthesia face mask, Rusch reusable anatomical black rubber pediatric mask
Patients will be ventilated trough an oral mask first and trough a face mask thereafter
| Study group | Role | What they receive |
|---|---|---|
| Face Mask | Active comparator | Patients will be ventilated with a face mask first and with a oral mask thereafter Receives: Device: Face Mask |
| Oral Mask | Experimental | Patients will be ventilated trough an oral mask first and trough a face mask thereafter Receives: Device: Oral Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
assessment will be done after extubation, when the spontaneous respiratory rate is 10 breaths/min.
Measured: 5 min after extubation
Secondary outcomes (1)
Mask ventilation grade of the patients as Grade0, grade 1, Grade 2, grade 3, grade 4
Assessment will be done after extubation
Measured: 5 min after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal Septum DeviationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Murat Sayın, Ass Prof, Study director, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869673
- Sponsor's protocol ID
- ORALMASK
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19923495Joffe 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.
PubMed 20808210
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Face Mask and Oral Mask Ventilation After Nasal Surgery.
- ClinicalTrials.gov ID
- NCT01869673
- Acronym / sponsor ID
- ORALMASK
- Conditions
- Nasal Septum Deviation
- Keywords
- Difficult mask ventilation, extubation, nasal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Detailed description
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.
The respiratory parameters will be measured with the monitor contained in the Drager Primus anesthesia machine. The observer providing mask ventilation is experienced in mask ventilation and will be blinded to the monitor display. All patients will be ventilated by the same observer. Data will be recorded by independent residents. The mask ventilation classification will be recorded. mean airway pressure (Pmean), maximum airway pressure (Ppeak) , tidal volume (TV), expired tidal volume (TVe) minute volume leak (MVleak) and minute volume (MV) will be recorded during spontaneous ventilation. Volatile anesthesia will be ceased after observing that the patients are calm and not coughing and the respiratory measures will be evaluated thereafter. The APL (airway pressure release) valve will be closed during the evaluation of mask ventilation. Sufficient chest movement, mask leak, gastric insufflations will be assessed. Indicators for difficult mask ventilation are defined as; TV< 4 ml kg, inadequate chest movements, the need for an oropharyngeal airway, two handed mask ventilation, need to increase the gas flow, gastric insufflations, need to ventilate with two operators.
It was planned to enroll 30 patients in this study. After performing a pilot study we calculated that 10 patients in each group was sufficient to detect a difference between groups concerning tidal volume with 0.95 power and 0.05 alfa error. We decided to enroll 24 patients in the study due to possible drop outs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face Mask | Active comparator | Device: Face MaskPatients will be ventilated with a face mask first and with a oral mask thereafter |
| Oral Mask | Experimental | Device: Oral MaskPatients will be ventilated trough an oral mask first and trough a face mask thereafter |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical class I or II
- adult patients
- ageing 19-45 yr
- scheduled for nasal surgery
Key exclusion criteria (7 listed)
- Respiratory diseases
- snoring
- smoking
- obstructive sleep apnea
- obesity (body mass index >30 kg m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face MaskAlso: Adult anesthesia face mask, Rusch reusable anatomical black rubber adult face maskPatients will be ventilated trough a face mask first and trough a oral mask thereafter | Device | Face Mask |
| Oral MaskAlso: Pediatric anesthesia face mask, Rusch reusable anatomical black rubber pediatric maskPatients will be ventilated trough an oral mask first and trough a face mask thereafter | Device | Oral Mask |
Primary outcome
Tidal volume
Time frame: 5 min after extubation
assessment will be done after extubation, when the spontaneous respiratory rate is 10 breaths/min.
1 secondary outcome
Mask ventilation grade of the patients as Grade0, grade 1, Grade 2, grade 3, grade 4
Time frame: 5 min after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Background: PubMed 19923495Salem 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.
- Background: PubMed 20808210Joffe 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.
Related trials for Nasal Septum Deviation
Not yet recruitingObservational study
Clinicoradiological Correlation Between Long Standing Untreated Adenoids and Nasal Septum Deviation in Adolescents
Nasal Septum Deviation
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Not yet recruitingObservational study
Effect of Controlled Hypotension on GFAP and Cognition in Rhinoplasty
Nasal Septum Deviation, Rhinoplasty
Active, not recruitingObservational study
Comparison of Laryngeal Mask and Tracheal Intubation With and Without Topical Lidocaine Application
Comparison of Airway Management Techniques in Functional Endoscopic Sinus Surgery, Rhinosinusitis With Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat Sayın, Ass Prof study director
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Face Mask and Oral Mask in people with Nasal Septum Deviation, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: 5 min after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.