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Intra oral (inside mouth) mask for mask ventilation under anaesthesia in patients without teeth

NU MASK (INTRA ORAL MASK IOM®) FOR MASK VENTILATION IN ANAESTHETIZED EDENTULOUS PATIENTS-A SINGLE ARM, INTERVENTIONAL STUDY (NUMERO STUDY) - NuMERO STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030459
Enrollment
43
Registered
2021-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Mask Ventilation by NuMASK: In all patients an oropharyngeal airway supplied with Nu mask will be placed and an appropriate sized (medium or large) intraoral mask will be placed behind

Sponsors

Tata Memorial Hospital Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Edentulous adult patients (age 20-90) of either sex, ASA class 1-3, undergoing surgeries under anaesthesia or examination under anaesthesia and requiring mask ventilation.

Exclusion criteria

Exclusion criteria: 1)Patients with less than 2 finger breadth mouth opening 2)Patients undergoing fiberoptic intubation 3)Patients with head and neck oncology having intraoral wounds, intraoral tumours, hypopharyngeal and laryngeal tumors 4)Patients with other factors of difficult mask ventilation like history of sleep apnea, body mass index >35 kg/m2 and reduced thyromental distance ( <5 cm)

Design outcomes

Primary

MeasureTime frame
Primary outcome measure will be successful mask ventilation in at least 80% (11 successful breaths) of 14 breaths delivered in a minute.Timepoint: For one minute after placing the NuMask

Secondary

MeasureTime frame
Secondary outcome measures will be number of successful breaths in each patient in one minute, peak inspiratory pressure in each breath, end-tidal carbon dioxide, end-tidal oxygen in each breath and complications if any.Timepoint: One minute after placing the NuMask

Countries

India

Contacts

Public ContactDr Sohan Lal Solanki

Tata Memorial Hospital, Mumbai

sohan.solanki@gmail.com9869253201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026