Comparison of different supraglottic airway devices following tracheal extubation

Comparison efficacy and safety of the SLIPA and I-gel versus laryngeal mask following tracheal extubation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016100514056N10

Enrollment

105

Registered

2016-10-24

Start date

2016-07-25

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Extubation. Failure to introduce or to remove other tube or instrument

Interventions

Intervention 1: In first group laryngeal mask insert inferior to a tracheal tube with empty cuff then extubation perform and ventilation continue with laryngeal mask. Intervention 2: In first group S

Prevention

In first group laryngeal mask insert inferior to a tracheal tube with empty cuff then extubation perform and ventilation continue with laryngeal mask.

In first group SLIPA insert inferior to a tracheal tube then extubation perform and ventilation continue with SLIPA.

In first group I-gel insert inferior to a tracheal tube then extubation perform and ventilation continue with I-gel .

Eligibility

Sex/Gender

All

Age

15 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ASA class I and II; Age 15 to 70 years old; Duration of surgery between 120 to 180 minutes; Supine position. Exclusion criteria: Difficult airway (Mallampati class III and IV); History of Gastroesophageal Reflux Disease; History of Chronic Obstructive Pulmonary Disease; Pregnancy; Body mass index greater than 30; Facial, head and neck surgery; Surgery duration less than 120 and greater than 180 minutes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Amount of cough. Timepoint: record until full consciousness. Method of measurement: Observation.;Amount of laryngospasm. Timepoint: record until full consciousness. Method of measurement: Observation.;Airway obstruction. Timepoint: record until full consciousness. Method of measurement: Observation.;Apnea. Timepoint: record until full consciousness. Method of measurement: Observation.;Respiration trap. Timepoint: record until full consciousness. Method of measurement: Observation.;Gag reflux. Timepoint: record until full consciousness. Method of measurement: Observation.;Vomiting. Timepoint: record until full consciousness. Method of measurement: Observation.;Need to reintubation. Timepoint: record until full consciousness. Method of measurement: Observation.	—

Measure

Time frame

Amount of cough. Timepoint: record until full consciousness. Method of measurement: Observation.;Amount of laryngospasm. Timepoint: record until full consciousness. Method of measurement: Observation.;Airway obstruction. Timepoint: record until full consciousness. Method of measurement: Observation.;Apnea. Timepoint: record until full consciousness. Method of measurement: Observation.;Respiration trap. Timepoint: record until full consciousness. Method of measurement: Observation.;Gag reflux. Timepoint: record until full consciousness. Method of measurement: Observation.;Vomiting. Timepoint: record until full consciousness. Method of measurement: Observation.;Need to reintubation. Timepoint: record until full consciousness. Method of measurement: Observation.

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Secondary

Measure	Time frame
Arterial oxygen saturation. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: Puse oximeter.;Blood pressure. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: sphygmomanometer.;Pulse rate. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: pulse rate in 1 minute.;Respiratory rate. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: Respiratory rate in 1 minute.	—

Measure

Time frame

Arterial oxygen saturation. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: Puse oximeter.;Blood pressure. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: sphygmomanometer.;Pulse rate. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: pulse rate in 1 minute.;Respiratory rate. Timepoint: every 5 minutes after insertion of supraglottic devices until full consciousness. Method of measurement: Respiratory rate in 1 minute.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hesameddin Modir

Arak University of Medical Sciences

He_modir@yahoo.com+98 86 3417 3641

Outcome results

None listed

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