Ventilation with a mask in edentulous patients undergoing heart surgery: the usual method or the method of blocking the mouth with mask cushion

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180724040575N7

Enrollment

Registered

2025-09-01

Start date

2025-09-23

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

Condition 1: Patients undergoing cardiac surgery. Condition 2: toothless patient.

Interventions

Intervention 1: Intervention group: Ventilating with an intraoral mask (blocking the mouth with the lower part of the mask cushion). Intervention 2: Control group: Mask ventilation in the usual way (

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who are candidates for cardiac surgery Having no natural teeth Having informed consent

Exclusion criteria

Exclusion criteria: Restricted mouth opening emergency operation

Design outcomes

Primary

Measure	Time frame
Peripheral blood oxygen saturation. Timepoint: while holding the mask. Method of measurement: pulse oxymeter.;Possibility of ventilation with one hand. Timepoint: while holding the mask. Method of measurement: inspection.;Inspiratory tidal volume. Timepoint: while holding the mask. Method of measurement: Anesthesia machine monitor.;Exspiratory tidal volume. Timepoint: while holding the mask. Method of measurement: Anesthesia machine monitor.;Amount of air leak. Timepoint: while holding the mask. Method of measurement: The difference between inspiratory and expiratory tidal volumes.	—

Measure

Time frame

Peripheral blood oxygen saturation. Timepoint: while holding the mask. Method of measurement: pulse oxymeter.;Possibility of ventilation with one hand. Timepoint: while holding the mask. Method of measurement: inspection.;Inspiratory tidal volume. Timepoint: while holding the mask. Method of measurement: Anesthesia machine monitor.;Exspiratory tidal volume. Timepoint: while holding the mask. Method of measurement: Anesthesia machine monitor.;Amount of air leak. Timepoint: while holding the mask. Method of measurement: The difference between inspiratory and expiratory tidal volumes.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKamal Fani

Shahid Beheshti University of Medical Sciences

kamalfani@sbmu.ac.ir+98 21 2207 4095

Outcome results

None listed

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