Outcome of calorie titration based on diaphragmatic excursion in mechanically ventilated ICU Patients a prospective randomized controlled trial.

Our study focuses on trying to  avoid the detrimental effects of overfeeding and underfeeding with the concept that in patients with lower diaphragm excursion less supplementation of the calorie will result in lower amount of overfeeding complications such as less oxidative stress and less free radical generation and less workload of the lungs  and will put less stress in the respiratory system and thereby avoiding diaphragm dysfunction , organ failure from insulin resistance endogenous hyperglycemia and free radical injury

Rationale of the study supported by cited literature

Diaphragm dysfunction, measured by Diaphragm excursion are correlated with MNUTRIC scores indicated as an indirect marker of malnutrition , and its efficacy in prevention of overfeeding and underfeeding complications in ICU patients and its role in weaning outcome from mechanical ventilation

HypothesisWe hypothesize that calorie adjustment based on diaphragm excursion during the initial 1 week  prevent the consequences of overfeeding and underfeeding  complications in critically ill patients as malnutrition are associated with significant diaphragm dysfunction in critically ill patients  .

Research questionsDoes calorie titration based on diaphragm excursion prevent the complications of overfeeding and underfeeding in mechanically ventilated ICU patients.

AimTo prove that calorie titration based on diaphragm excursion overcomes the effects of underfeeding or overfeeding complications in mechanically ventilated ICU patients

PRIMARY OBJECTIVE Weaning of mechanically ventilated patients between  titrated calorie administration during the initial 1 week  and fixed calorie administrat

SECONDARY OBJECTIVES

to assess diaphragm thickness, diaphragm excursion in all the groups.

Serum phosphate level in prevention of refeeding syndrome and consequent diaphragmatic dysfunction

IL-6 a marker of oxidant injury among both groups

Difficulty in weaning from the mechanical ventilator

To assess the efficacy and outcome of patients who undergo graded increase in nutrition and its effects of overcoming the abrupt transition of overfeeding vs underfeeding states in critically ill patients

To assess the Gastrointestinal intolerances among both groups

Incidence of hyperglycemia events among both groups (Blood glucose>180)

Detailed methodology

This is a single center prospective randomized  controlled study

Patients  fulfilling  inclusion criteria will be randomly allocated into two groups and allocation concealed using sealed envelope method.

GROUP A  Mechanically ventilated patient undergoing  calorie titration based on  diaphragm excursion velocity

GROUP B Mechanically ventilated patients undergoing fixed   25kcals/kg/day

The study will be conducted in mechanically ventilated patients of acute hypoxic respiratory failure patient  for the first day of intubation to 5 th day of intubation

Ultrasound imaging of diaphragmatic excursion velocity  will be assessed in mechanically ventilated patients at a pressure support of 5 cm H2O of group A and will be fed accordingly

Excursion  of less than 1 cm_ 10 kcals/kg

Excursion  of 1-2 cm-   20kcals/kg

Excursion  of  2-3cm-30kcals/kg

GroupB Group B will be fed with usual 25kcals/kg

Patients will be randomized into two groups , group A and group B, who are undergoing mechanical ventilation and from the day one of intubation their calorie feeds will be delivered according to the above protocols for the respective groups , There is no titration of protein calories and it is given at 1.3 gm to 1.5 gm/kg among both the groups.

Usg diaphragm assessment will be done with the help of linear and phased array probe and diaphragm thickness fraction and diaphragm excursion  will be calculated among both the groups on a daily basis and noted

Day 5 th diaphragm thickness fraction and Diaphragm excursion  will be taken as the final reading for the primary objective assessment

Diaphragm thickness will be assessed with the help of linear probe at the zone of opposition by keeping the linear probe parallel to the anterior axillary line and putting the M mode across the zone of opposition and calculating the diaphragm thickness, with the normal range being above 30 %

Diaphragm excursion  will be calculated with the help of phased array probe placed at the subcostal level and placing the M mode along the diaphragm excursion and calculating its excursion  with the normal range between 1-2 cm

These measurements are made at the level of pressure support of 5 cm in spontaneous pressure support mode of ventilation

Baseline routine investigations consisting of Complete blood count, Renal function test, Liver function test, Procalcitonin , D-dimer parameters will be recorded among the two groups

Serum phosphate level on day 2 will be assessed among the both groups and complications and incidence of refeeding syndrome will be monitored

Random blood glucose monitoring ( 4 readings /day) for the 5 days will be taken into account, Rbs of more than 180 will be considered as hyperglycemia and Rbs of < 70 will be considered as Hypoglycemia

Diarrhea/Abdominal pain /Constipation episodes , and any other symptoms of gastro intolerance will be documented among both groups

Baseline vasopressor support, single reading of  vitals on day 1 to day 5 will be documented

Patients undergoing high amounts of hemodynamic instability such as refractory vasopressor support, MAP < 65 will be excluded from the study

Dieticians help will be obtained for the administration of calculated amount of calories and advice will be followed

Renal, hepatic, diabetic diet will be followed and be administered based on the amount of calorie as per the protocol

Inclusion criteria

Age>18

Mechanically ventilated patients in ICU  in view of respiratory distress/altered sensorium

Exclusion criteria

•       Refusal of informed consent

•         Known case of phrenic nerve injury

•        Patients with chest trauma, abdominal trauma

•         Patients with pathologies related to increased abdominal pressure

•         Patients with neuromuscular muscular diseases

•         Continuous infusion of muscle-paralyzing agents

•

•         presence of thoracotomy, pneumothorax or pneumo-mediastinum, pregnancy

Sampling population Patient admitted to ICU who satisfy the inclusion criteria

Sample size of our study is calculated on basis of a study done by Yifei Wang et al on impact of early high protein intake in critically ill patients ,a RCT, where the Mechanical ventilation duration mean days were found to be 9 vs 10.25 in the test and reference group

Assuming a pooled standard deviation of 1.88

Sample size for each group is found to be 36 in each group

Hence  2 groups  comprising a total sample size of 72 is obtained

To achieve a power of 80 %

And a level of significance of 5%

Sample size is calculated by using by Two independent means formula

Data analysis plan: Data will be collected using google form.

Statistical analysis of the data will be performed using SPSS Latest version available.

The Q-Q plot will be used to understand the distribution of continuous outcome variables.

Continuous variables will be expressed as mean ± standard deviation/ Median (IQR)  depending on its distribution and categorical variable as frequency (percentage).

Comparisons will be performed by one-way analysis of variance (ANOVA) followed by Tukey’s Post-hoc test for normally distributed or  Kruskal–Wallis test for non-normally distributed, and chi-square test of association for categorical variables.

A p-value of < 0.05 will be considered to be statistically significant.