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Comparison Of Two Types of Endotracheal Tubes in Anesthesia for Cleft Palate Surgeries

Comparison Of Microcuff and Uncuffed Preformed Endotracheal Tubes in Cleft Palate Surgeries â?? A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008523
Enrollment
100
Registered
2017-05-09
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: null- Cleft palate undergoing palatoplasty under GA

Interventions

Intervention1: MicroCuff Preformed Endotracheal Tube: Size determined by manufacturer recommendations Control Intervention1: Uncuffed preformed endotracheal tube: Size determination as per Motoyama fo

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA 1 and 2 children posted for elective cleft palate surgery

Exclusion criteria

Exclusion criteria: 1. Limited mouth opening ( 2. Anticipated difficult airway in syndromic patients with cleft palate where conventional Macintosh laryngoscopy may not possible. 3. History of recent respiratory tract infection. 4. Evidence of pulmonary diseases (pneumonia, asthma, pulmonary malformation)

Design outcomes

Primary

MeasureTime frame
ï?§ To compare the tube exchange requirement (once or more than once) and leak pressure ï?§ To determine whether the cuff needs to be inflated in Microcuff tubes (yes/no) ï?§ To determine the cuff position ultrasonographically for Microcuff tubes Timepoint: At time of intubation and immediately after connecting to ventilator, leak pressure will be measured, and tube exchange will be noted. Based on that, cuff will or will not be inflated. Cuff position will be determined by USG after connecting the patient to ventilator

Secondary

MeasureTime frame
assess ventilatory parameters (VTE,PAW, EtCO2,SpO2)Timepoint: at baseline, after extension of the head and after applying the mouth gag;Monitor cuff pressure when anesthesia is maintained with sevoflurane and oxygenTimepoint: at baseline and thereafter every 15 minutes;report associated airway morbidity, if any (airway edema, postoperative sore throat, intra-op extubationTimepoint: intraop and 24h postop;To find evidence of endobronchial intubationTimepoint: immediately following intubation;To measure carina to tube tip distance at neutral position and head extension (by fibreoptic bronchoscopy)Timepoint: following intubation

Countries

India

Contacts

Public ContactDr Rithu Krishna K

JIPMER

jipmermishra@gmail.com9344668104

Outcome results

None listed

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