Comparison of Nasal Mask and Face Mask Ventilation on Air Leak in Obese Adults Undergoing Surgery: A Randomized Controlled Study

Effect of nasal mask versus face mask ventilation on mean air leak in class 2 and class 3 obese adult patients undergoing elective surgery under general anaesthesia: a randomised controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093904

Enrollment

Registered

2025-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: R635- Abnormal weight gain

Interventions

Intervention1: Mask ventilation: Effectiveness of Face Mask vs Nasal mask ventilation Intervention2: GROUP B- Face Mask ventilation: Group B patients will be taken in RAMP position. preoxygenation wil

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of either gender between age group 18-65 years of class 2 and class 3 obesity undergoing elective surgery under general anaesthesia ASA-PS III

Exclusion criteria

Exclusion criteria: Patients not willing to give consent Patients with maxillofacial trauma Parturients Edentulous patients

Design outcomes

Primary

Measure	Time frame
To compare the mean air leak volume in nasal and face mask ventilation in anaesthetized class 2 and class 3 obese adults undergoing general surgeryTimepoint: Ten readings will be taken During three minutes of mask ventilation via face mask or nasal mask. The average or mean of ten readings will be taken	—

Secondary

Measure	Time frame
To compare Mean expired tidal volume in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes ;To compare Mean PIP in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean Pplat in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean SpO2 in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean EtCO2 in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean leak fraction in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Difference in gastric residual volume in the nasal versus face mask ventilation groupTimepoint: first reading will be taken pre-operatively, next reading after three minutes of bag & mask ventilation after securing the airway, then the mean difference between these two readings will be calculated at the end of 3 minutes	—

Measure

Time frame

To compare Mean expired tidal volume in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes ;To compare Mean PIP in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean Pplat in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean SpO2 in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean EtCO2 in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Mean leak fraction in the nasal versus face mask ventilation group Timepoint: For first 10 breaths during mask ventilation via face mask or nasal mask at the end of 3 minutes;To compare Difference in gastric residual volume in the nasal versus face mask ventilation groupTimepoint: first reading will be taken pre-operatively, next reading after three minutes of bag & mask ventilation after securing the airway, then the mean difference between these two readings will be calculated at the end of 3 minutes

—

Countries

India

Contacts

Public ContactDR GOPAL KRISHAN JALWAL

AIIMS BATHINDA

navnehsamagh@gmail.com8427264480

Outcome results

None listed

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