Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants
Klíčová slova
Abstraktní
Popis
Trial Objective: To determine whether estimating ETT insertion depth using gestational age chart rather than nasal-tragus length method results in more correctly positioned ETT tips.
Setting: The neonates will be recruited from multiple tertiary-level neonatal intensive care units in Saudi Arabia. A neonate can participate in more than one clinical trial, depending on the interventions being given. Parallel run trials will be discussed between the chief and local principal investigators whether or not joint recruitment is feasible to both parties.
Informed Consent: We will obtain written consent after the parents have been given a full verbal explanation and written description. We will explain to the parents in their own native language. We will use a hospital-based adult interpreter wherein required. We will obtain deferred consent (after initial verbal assent) where prior consent is not feasible as the study does not involve additional risk or investigations to the participants, and the interventions are otherwise considered as standard practice recommendations by the NRP.
Data Safety Monitoring Board: Any unexpected serious events (death, any life-threatening event, any event that will prolong the hospitalization or any event that will result in disability) will be reported to the data safety monitoring committee. The trial steering committee will receive recommendations from the data safety monitoring board if the trial requires early termination following the interim data analyses and evidence from relevant studies. The following measures were agreed to consider stopping the trial, wholly or partly (subgroups), after an interim analysis, that will be done after recruiting 200 participants.
1. An absolute difference of greater than or equal to 25% in the primary outcome between the study groups.
2. An absolute difference of less than 5% in the primary outcome between the study groups.
3. A rate of less than 20% in the primary outcome in either of the groups.
Sample Size: Our unpublished data showed using the nasal-tragus length method results in 35% of correctly positioned ETT tips in term and preterm infants. The data is similar to the randomized and non-randomized studies that showed an accuracy between 32 and 37 percent using the nasal-tragus length method. With 90% power and two-sided 5% significance, to detect an absolute increase in optimally positioned ETT tips of 15%, we will require 454 participants. We calculated sample size using nQuery Advisor Sample Size Calculator version 8.3.0.0.
Statistical Analysis: We will analyze the data based on the intention-to-treat principle. Univariate analyses will be performed to compare baseline demographic factors between the two groups. A mean with standard deviation (normal data) or median with interquartile range (skewed data) will be obtained for continuous variables and numbers and percentages for categorical variables. Independent T-test (normal data) or Mann Whitney U test (skewed data) for continuous variables and chi-square test (or Fisher's exact test as appropriate) for categorical variables will be used for analyses between the groups. Statistical Analysis Software version 9.4 will be used for the conduct of all analyses.
Analysis of primary outcome: Adjusted risk ratios of a successful outcome will be calculated along with 95% confidence intervals. Adjusted ratios will be determined by way of multivariable logistic regression analysis, including co-variates deemed biologically to have an influence on the primary outcome (gestational age, small for gestational age, and center). Principles of best model practices will be followed (including assessment of collinearity amongst included variables) as well as the determination of the predictive ability of the model using area under the curve.
Analysis of secondary outcomes: Similar analyses as above will be performed for all secondary outcomes that are categorical variables. The risk ratios of secondary outcomes mortality, oxygen therapy at 28 days, pneumothorax, and bronchopulmonary dysplasia will be adjusted based on the following variables: gestational age, male sex, small for gestational age, maternal hypertension, chorioamnionitis, antenatal steroids, and center if the P-value is less than 0.25 on univariate analysis.
Termíny
Poslední ověření: | 04/30/2020 |
První předloženo: | 05/10/2020 |
Odhadovaná registrace vložena: | 05/12/2020 |
První zveřejnění: | 05/18/2020 |
Poslední aktualizace byla odeslána: | 05/12/2020 |
Poslední aktualizace zveřejněna: | 05/18/2020 |
Aktuální datum zahájení studie: | 05/31/2020 |
Odhadované datum dokončení primární: | 05/31/2022 |
Odhadované datum dokončení studie: | 08/31/2022 |
Stav nebo nemoc
Intervence / léčba
Other: Gestational Age Chart Method
Other: Nasal-Tragus Length Method
Fáze
Skupiny zbraní
Paže | Intervence / léčba |
---|---|
Experimental: Gestational Age Chart Method In this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092) | Other: Gestational Age Chart Method The endotracheal tube insertion depth is obtained by the gestational age chart |
Active Comparator: Nasal-Tragus Length Method In this method, the endotracheal tube insertion depth is calculated based on the formula—the distance from nasal septum tip to ear tragus+1 cm | Other: Nasal-Tragus Length Method The endotracheal tube insertion depth is obtained by the nasal-tragus method formula |
Kritéria způsobilosti
Pohlaví způsobilá ke studiu | All |
Přijímá zdravé dobrovolníky | Ano |
Kritéria | Inclusion Criteria: - Infants (less than 28 days of life) between 23 weeks 0 days and 41 weeks 6 days gestational age - Infants requiring oral intubation in the delivery room or in neonatal intensive care unit Exclusion Criteria: - Infants with major chromosomal anomalies, including trisomy 13, trisomy 18, and trisomy 21 - Infants with major anomalies, including craniofacial anomalies and facial dysmorphism that may affect the nasal-tragus length |
Výsledek
Primární výsledná opatření
1. Optimally positioned endotracheal tube tip on the chest X-ray [within 4 hours of endotracheal intubation]
Měření sekundárních výsledků
1. Endotracheal tube tip above T1 vertebra [within 4 hours of endotracheal intubation]
2. Endotracheal tube tip below T2 vertebra [within 4 hours of endotracheal intubation]
3. Pneumothorax [36 weeks of post-menstrual age]
4. Endotracheal tube repositioning (advance or withdrawn) following chest X-ray [24 hours]
5. Oxygen therapy [28 days from the birth]
6. Bronchopulmonary dysplasia [36 weeks of post-menstrual age]
7. Ventilation days [36 weeks of post-menstrual age]
8. Mortality [36 weeks of post-menstrual age]