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Endotracheal tube cuff pressure estimation techniques: safety and reliability among women undergoing general anaesthesia with intubation for cesarean section

Endotracheal tube cuff pressure estimation techniques: safety and reliability among parturients undergoing general anaesthesia with intubation for cesarean section at the obstetric unit of the Tamale Teaching Hospital. A prospective randomized comparative study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66168037
Enrollment
380
Registered
2021-07-16
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-11-22

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

Conditions

Elective cesarean section Pregnancy and Childbirth

Interventions

All parturients are prospectively assessed and classified according to the American Society of Anesthesiologists (ASA) physical status classification. Basic intraoperative monitoring (ECG, SpO2, tempe
standard manometer, predetermined volume of air (10 - 15 ml), or manual palpation of the endotracheal tube pilot balloon immediately after intubation. Again, prior to extubation, the pressure gauge is

Sponsors

Habana Medical Services
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Parturients scheduled for elective cesarean section under general anaesthesia with endotracheal intubation 2. Aged 18 to 40 years 3. American Society of Anesthesiologists Physical Status (ASA-PS) score 1-2

Exclusion criteria

Exclusion criteria: 1. Patients with a history of difficult intubation or multiple attempts (more than three attempts) during intubation 2. Parturient requiring emergency intubation 3. Parturient with a higher risk for aspiration 4. Intubation performed by non-anaesthesia staff 5. Parturient with known anatomical laryngotracheal abnormalities 6. Those expected to remain intubated beyond the operation room period

Design outcomes

Primary

MeasureTime frame
1. Endotracheal tube cuff pressure determined using a standard manometer, predetermined volume of air (10 - 15 ml), or manual palpation of endotracheal tube pilot balloon immediately after intubation or prior to extubation. The technique used and the cuff pressure estimated in each group is recorded 2. Cuff pressure associated complications (cough, sore throat, hoarseness, and blood-streaked expectoration) determined during an interview after 24 hours of extubation

Secondary

MeasureTime frame
Overall perioperative satisfaction, evaluated as 4 = excellent, 3 = good, 2 = satisfactory, 1 = poor, during an interview on the day of discharge

Countries

Ghana

Outcome results

None listed

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