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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00951860 -
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
|
N/A | |
Recruiting |
NCT05601375 -
Speckle Tracking Echocardiography in Infants, Prenatally and Postnatally
|
||
Terminated |
NCT04025021 -
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
|
N/A | |
Recruiting |
NCT05965830 -
Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
|
||
Completed |
NCT04904965 -
Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.
|
N/A | |
Recruiting |
NCT05835817 -
Magnetoencephalography by Optical Pumping Magnetometer
|
N/A | |
Recruiting |
NCT04905732 -
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
|
N/A | |
Completed |
NCT04794881 -
Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates
|
N/A | |
Recruiting |
NCT04795453 -
Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients
|
||
Completed |
NCT03103022 -
Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus
|
Phase 1 | |
Completed |
NCT05197868 -
Applied Forces During Neonatal Intubation
|
N/A | |
Withdrawn |
NCT05045092 -
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
|
||
Withdrawn |
NCT05075486 -
Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support
|
N/A | |
Withdrawn |
NCT05085080 -
Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
|
||
Recruiting |
NCT05181423 -
Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery
|
||
Completed |
NCT05104255 -
Neonatal Outcomes in Twin Pregnancies
|
||
Completed |
NCT03082001 -
Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies
|
Phase 3 | |
Not yet recruiting |
NCT05934682 -
Latin American Surgical Outcomes Study in Pediatric Patients
|
||
Completed |
NCT04937348 -
Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
|
||
Completed |
NCT04464057 -
Safety and Effectiveness of Early Feeding After Bowel Anastomosis in Neonates or Infants
|
N/A |