Neonate Clinical Trial
Official title:
Cuffed Versus Uncuffed Tracheal Tubes in Neonates Undergoing Elective Surgery: a Double Blinded Randomized Controlled Trial
Verified date | December 2023 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This thesis aims to assess the safety and efficacy of usage of cuffed ETT in neonate undergoing elective surgeries.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 19, 2023 |
Est. primary completion date | December 19, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 1 Month |
Eligibility | Inclusion Criteria: - • Neonates (infant in the first 28 days after birth) - Full term (more than 37 gestational weeks) - More than 3 kg bodyweight - ASA I-II - Scheduled for elective surgeries under general anesthesia requiring endotracheal intubation. Exclusion Criteria: - • Parents or legally authorized personnel refusal. - Anatomical abnormalities of upper air way. - Emergency surgery. - Low birth weight less than 3 kg - Surgery longer than 2 hours - Premature neonates - Upper airway surgery - Requirement for postoperative ventilation |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasralainy | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of ETT exchange to find the appropriate ETT | the incidence of ETT exchange to find the appropriate ETT defined as:(the absence of resistance to insertion of the tube and the presence of audible leak with inflation pressures of 20 cmH2O). | 2 hours | |
Secondary | Duration of intubation | calculated from time from the introduction of the laryngoscope blade to the mouth till the first trace of capnography recorded. | 10 minutes | |
Secondary | Leakage around the ETT | defined as the mean of three readings of difference between inspiratory and expiratory tidal volumes (as measured by the anesthesia machine) at T0: after intubation, T1: immediately after recruitment, T2: 10 min after recruitment, T3: 20 min after recruitment, T4: at the end of surgery. | 2 hours | |
Secondary | Number of attempts to insert and correctly size the tracheal tube. | Number of attempts to insert and correctly size the tracheal tube. | 10 minutes | |
Secondary | Desaturation incidence | (SPO2 less than 95%) at 1 min, 5 min, 10 min, 15 min, 20 min and 30 min postoperatively. | 30 minutes postoperative | |
Secondary | Hoarseness of voice. | Hoarseness of voice. Graded as follow:
0= no hoarseness (good high-pitched cry sound) mild hoarseness (good cry but soft whispering low-pitched sound) severe hoarseness (cry but no audible sound) |
30 minutes postoperative | |
Secondary | Croup incidence | Croup (defined as triad of barking cough, stridor and a hoarse voice). | 30 minutes postoperative |
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