Weaning refers to the shift from ventilator support to totally spontaneous breathing, during which the patient bears responsibility for efficient gas exchange while positive support is stopped. Notably, spontaneous breathing is a prerequisite for weaning to begin, and decreasing ventilator use is not the only criterion for weaning success. In contrast, "extubation" refers to removing the endotracheal tube. Extubation criteria include spontaneous breathing, hemodynamic stability, intact airway reflexes, and controllable respiratory secretions used to denote the reduction in ventilator support over time.[1] Weaning is expected to consume 40 per cent of the whole period of mechanical ventilation. Delay in weaning may result in consequences such as ventilator induced lung injury (VILI), ventilator associated pneumonia (VAP), an increased risk of venous thromboembolism and gastrointestinal bleeding, and ventilator induced diaphragmatic dysfunction. Premature weaning, on the other hand, might result in difficulties such as airway obstruction, improper gas exchange, aspiration, and respiratory muscle exhaustion.[2] Weaning patients after a time of ventilation is a challenge for intensivists and respiratory care staff, and commencing a spontaneous breathing trial (SBT) is the simplest intervention to determine readiness for extubation.[3] Spontaneous Breathing Trial on a T-piece or a combination of pressure support (PS) and continuous positive airway pressure (CPAP) are the most often employed therapies. The spontaneous breathing trial (SBT) evaluates a patient's capacity to breathe with minimal or no assistance from a ventilator. The collective task force recommended in 2001 that SBT and weaning should begin with a determination of whether or not the underlying cause of respiratory failure has been treated. There is no unanimity regarding the evaluation criteria for reversal of the underlying disease. Typically, a combination of subjective and objective criteria is employed to determine the reversal of a disease. Typically, improvement in gas exchange, mental status, neuromuscular functional assessment, and radiographic indications are employed as diagnostic criteria.[4] It should be noted, however, that some patients who do not satisfy these criteria are finally weaned effectively.[5] Despite the significance of limiting time on mechanical breathing, the Paediatric literature provides scant information on weaning and extubation

Aim of the study

Was to compare the extubation outcome of two weaning methods i.e., CPAP and T-piece trial for extubation in mechanically ventilated patients in pediatric ICU

Study Setting: The study was conducted in Department of Paediatric, Career Institute of medical sciences, Lucknow from May 2022-April 2023

Study Design: Prospective observational study

INCLUSION CRITERIA

• PICU admission age 1 month to 12 years
• Invasive mechanical ventilation for more than 24 hours
• Patients/guardians were giving written informed consent.

EXCLUSION CRITERIA

• Patient not giving consent.
• Weight less than 5 kg
• Died without weaning trial
• Tracheostomy
• Unplanned extubation
• Patients intubated for more than 14 days

Ethical approval

 It was taken from the Institutional Ethics Committee of the university. Ethical no.558/Ethics /2022

Statistical Analysis

Randomization was done as per a computer-generated random number table. An appropriate severity score was done for each case at the stipulated time

Data were entered in Microsoft Excel and analyzed using statistical software SPSS version 26 (SPSS Inc., Chicago, IL, USA). The continuous variables were evaluated by mean (standard deviation) or range value when required. The dichotomous variables were presented in number/frequency and were analyzed using Chi-square. Analysis by Student t-Test was used to compare the means between the two groups. A p-value of < 0.05 or 0.001 was regarded as significant.

Post taking ethical clearance from the institutional ethical committee and written informed consent from the guardians, 160 paediatric patients of age 1month to 12 years, admitted in the PICU and receiving invasive mechanical ventilation for more than 24 hours were enrolled for our study. Further, based on the weaning methods the total enrolled patients were randomly sub-divided into 2 groups CPAP [Continuous Positive Airway Pressure (n=80)] & T piece (n=80). Our study’s findings presented that in CPAP and T piece both the groups' majority of patients passed the adequate range of S.B.T. Only 7.50% of patients in CPAP and 3.75% of patients in T piece group failed to do so. Also, in both the group's majority of patients didn't face much difficulty at all

TABLE-1: Age distribution of the enrolled patients.

TABLE-2: Gender distribution of the enrolled patients.

Male dominance was observed in both the groups. In CPAP group the difference was huge as 70% patients were male and 30% were female. However, in T piece group this difference was comparable slightly as, 57.50% were male patients and remaining 42.50% were female patients. Further, statistically insignificant difference was observed among them (p=0.1001).

TABLE-3: General diagnosis of the enrolled patients

TABLE-4: No. of attempt for Success full S.B.T among the group.

Number of SBT were almost comparable, however T piece group had only 5% cases with prolong SBT time as compared to 11.25% in CPAP cases.

TABLE-5: First trial of extubation readiness of the enrolled patients.

The majority of the patients in T piece passed the first trial of readiness test (81.25%) where as in CPAP majority (77.50%) of the patients fail the first trial of extubation readiness test. However, a non-significant difference was observed in Readiness test.

The prospective cohort study was performed in the Department of Paediatrics, Career Institute of medical sciences, Lucknow, 160 paediatric patients aged one month to 12 years, admitted to the PICU and receiving invasive mechanical ventilation for more than 24 hours, were enrolled for our study. Further, based on the weaning methods, the total enrolled patients were randomly sub-divided into two groups CPAP [Continuous Positive Airway Pressure (n=80)] & T piece (n=80) groups According to MacIntyre NR et al. 2001 [2], the withdrawal of discontinuation of  mechanical ventilation is a critical clinical issue; according to the Evidence-Based Guidelines for Weaning and Discontinuing Ventilatory Support, Collective Task Force Facilitated by the American College of Chest Physicians, the American Association for Respiratory Care, and the American College of Critical Care Medicine.

In the present study, most of the patients in the CPAP group were aged between 5-10 years, i.e., 51.25%, followed by 0-5 years 37.50% patients. However, the maximum numbers of patients in the T piece group were aged between 0-5 years, i.e., 47.50%, followed by 5-10 years 30% patients. Similarly, according to Bairwet al., 2021 [6], a comparison of CPAP and T-piece as S.B.T. methods was performed. In both groups, age was comparable. There was no statistically significant difference between the two groups in terms of extubation failure within 48 hours was observed.

In current study, male preponderance along with lower class dominance was observed among total enrolled patients in both groups. Likewise, according to LJ et al., 2017 [7], among 216 studied patients, 64.35% were males and 35.64%) were females, with the ratio of M: F=1.8:1. Further, majority of patients entering mechanical ventilation practices in a pediatric intensive care unit (PICU) were from lower and middle socioeconomic classes.

In the present study, in the CPAP group and T piece group, most patients suffered from pneumonia, followed by suffering from acute encephalitic

syndrome. However, the least number of patients had leukaemia.

Further, in our research while analyzing the indicative parameters for mechanical ventilation, it was found that in the CPAP group and T-piece group, most of the patients suffered from respiratory distress, followed by patients having low Glasgow coma scale scores (3-8). However, the least number of patients were diagnosed with Severe subcostal retraction. However, in contrast to our research according to Kumar L et al., 2018 [8], patients reporting low GCS score were prominent. Our study’s findings presented that in CPAP and T piece both the groups' majority of patients passed the adequate range of S.B.T. Only 7.50% of patients in CPAP and 3.75% of patients in T piece group failed to do so. Also, in both the group's majority of patients didn't face much difficulty at all. Also, the rate of extubation failures did not differ significantly between the CPAP. and T-piece groups. The respiratory rate (R.R.) and heart rate (H.R.) were significantly higher (P<0.001) in the T-piece trial group, while saturation was decreased (P = 0.035).

 Comparing the Overall Outcomes in Enrolled Patients with the Previously Available Literature:

In CPAP and T piece groups of our study, majority of patients remained alive at the end of the protocol. Only 6.25% of patients in the CPAP group died during the procedure. However, a statistically significant difference was observed among them. Similarly, according to Bairwa RC et al., 2021 [6], there was no statistically significant difference was observed between the two groups (CPAP & T piece) in terms of extubation failure or death within 48 hours. In both groups, four patients were re-intubated, and two patients in the T-piece group and one patient in the CPAP group died.

In present study, the overall success rate was calculated in both groups, and it was found that the success rate was high in the T-piece group than that in the CPAP group. As in the T piece group, only 3.75% of patients faced failure; however, in the CPAP group, the failure rate was high, with 7.50% of patients. Similarly, according to Kumar L et al., 2018 [8], the rate of extubation failures did not differ significantly between the CPAP and T-piece groups as the success rate was comparably high in both the groups. At the beginning of weaning, the index of rapid shallow breathing was considerably greater in the T-piece group (P<0.001). The respiratory rate (R.R.) and heart rate (H.R.) were significantly higher (P<0.001) in the T-piece trial group, while saturation was decreased (P = 0.035). There may be some preceding risk factors leading to poorer outcome like hyponatremia,lack of early exposure to breastmilk ,genetic defects, frequent CNS or gastrointestinal infections, home delivery and nutritional deficiency[9-17].Like older children VAP is rampant in neonates as well[18].

In extreme scenarios within the present research, to enhance the overall success rate, re-intubation was required. However, for both techniques the observed success rate was high. Therefore, re-intubation was required only by single patients and, i.e. from the CPAP group only. Whereas, the still a statistically insignificant difference among them (p=0.3158). Similarly, according to Gopinath A 2018 [19], significantly fewer patients required re-intubation in the P.S.V. and CPAP group compared to the T-piece group. Patients who have undergone upper abdominal surgery can be weaned from a mechanical ventilator using Pressure support ventilation or a T-piece with O2-6L/min.

It was observed that the choice of weaning method may depends on the age regardless of gender as majority of patients directed for CPAP were aged between 5-10 years, and as majority of patients directed for T piece were aged between 0-5 years. However, the data may require further research-based support and non-significant difference was obtained at the end. Number of SBT were almost comparable, however T piece group had only 5% cases with prolong SBT time as compared to 13.75% in CPAP cases. Significantly, majority of the patients in T piece passed the first trial of readiness test. Further, the results of this study will also add to understanding of the reintubation rate, number of attempts and duration required for successful weaning. In fact, it offers a conceptual framework with recommendations for evidence-based best practices relating to the liberation from pediatric Ventilation

Limitation

• The sample size of 160 subjects for such a specifically important study was comparatively moderate. Larger sample size and multicentric analysis with high precision and accuracy may be recommended for a more reliable interpretation of results.
• To bypass the confounders and increase the reliability, the study needs to evade additional variables like more parameters and control groups also etc.
• Results were limited to a single tertiary care centre that may not be generalized for all settings. Hence, it cannot be incorporated into a larger population.

1. Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, et al. Evolution of mechanical ventilation in response to clinical research. *American journal of respiratory and critical care medicine*. 2008;177(2):170–7.
2. MacIntyre NR, Cook DJ, Ely EW Jr, Epstein SK, Fink JB, Heffner JE, et al. Evidence-based guidelines for weaning and discontinuing ventilatory support: a collective task force facilitated by the American College of Chest Physicians; the American Association for Respiratory Care; and the American College of Critical Care Medicine. *Chest*. 2001;120(6 Suppl):375s–95s.
3. Saeed F, Lasrado S. Extubation. [Updated 2020 Dec 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan. Available from: [https://www.ncbi.nlm.nih.gov/books/NBK539804](https://www.ncbi.nlm.nih.gov/books/NBK539804)
4. MacIntyre NR. The ventilator discontinuation process: an expanding evidence base. *Respiratory care*. 2013;58(6):1074–86.
5. Ely EW, Baker AM, Evans GW, Haponik EF. The prognostic significance of passing a daily screen of weaning parameters. *Intensive care medicine*. 1999;25(6):581–7.
6. Bairwa RC, Sagar H, Sapare AK, Aggarwal R. Comparison between continuous positive airway pressure and T piece as spontaneous breathing trial at a tertiary care pediatric intensive care unit: A pilot randomized control trial. *Journal of Pediatric Critical Care*. 2021 May 1;8(3):123.
7. Pham T, Brochard LJ, Slutsky AS. Mechanical ventilation: state of the art. *Mayo Clinic Proceedings*. 2017 Sep 1;92(9):1382–1400.
8. Kumar L, Meghalakshmi AR, Vasudevan A, Rajan S, Paul J. Comparison of extubation outcomes following T-piece trial versus pressure support/continuous positive airway pressure in postsurgical patients. *Indian J Respir Care*. 2018;7:37–4.
9. Verma A, Jain S, Abbas J. Hyponatremia and raised cardiac Troponin I in newborns are evocators of severe hypoxic ischemic encephalopathy. *African Journal of Biological Sciences*. 2024;6. doi:10.48047/AFJBS.6.14.2024.9480-9487.
10. Jain S, Kumar M, Tripathi S, Singh SN. Oral application of mother's own milk for prevention of late-onset sepsis in preterm very low birth weight neonates: a randomized controlled trial. *Breastfeed Med*. 2022 Jan;17(1):59–64. doi:10.1089/bfm.2021.0184. Epub 2021 Oct 29. PMID: 34714125.
11. Tripathi S, Jain S, Kumar M. Congenital neuronal ceroid lipofuscinosis: an important cause of unexplained seizures in newborns. *Indian Pediatr*. 2022 Sep 15;59(9):726–727. PMID: 36101955.
12. Jain S, Patil M, Abbas J. A case of Fanconi Bickel Syndrome with atypical presentation: A novel mutation. *Unpublished*; 2023.
13. Mishra A, Jaiswal S, Abbas J, Verma A, Jain S. Exploring the landscape of ventilator-associated pneumonia in pediatric intensive care: incidence, outcomes, and etiology. *Unpublished*; 2024. doi:10.47009/jamp.2024.6.1.87.
14. Jain S. A prospective observational study on compliance to a 14-day zinc treatment for acute diarrhea in under-5 children: are we failing at it? *Indian Journal of Applied Research*. 2023;57–58. doi:10.36106/ijar/7004701.
15. Mishra A, Jaiswal S, Abbas J, Verma A, Jain S. To study the prognostic factors in hemiparesis in children and correlate neuroimaging abnormalities to clinical characteristics: a prospective observational study. *International Journal of Medicine and Public Health*. 2024. doi:10.5530/ijmedph.2024.1.12.
16. Jain S, Abbas J, Malhotra R. Community-based survey on home births in urban slums in Lucknow: reasons and consequences. *International Journal of Science and Research (IJSR)*. 2023;12. doi:10.21275/SR23707125625.
17. Verma A, Jain S, Abbas J. Upsurge of iron deficiency anaemia and undernutrition among adolescents in North India. *African Journal of Biological Sciences*. 2024;6. doi:10.33472/AFJBS.6.14.2024.00-00.
18. Jain S, Beg S, Verma A. To study the relationship between Vitamin B12 deficiency in breastfed infants and their mothers and its clinico-hematological manifestations: A cross-sectional study. *Unpublished*; 2023.
19. Gopinath A. A prospective and randomized study for evaluating the effectiveness and safety of two strategies, pressure support ventilation (PSV) and T-piece ventilation for weaning adult patients from the mechanical ventilator. (Doctoral dissertation, Madras Medical College, Chennai).