Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery

Study Overview
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Brief Summary
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The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode

Detailed Description
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Obesity is an ongoing worldwide problem, and as such, weight-related issues arise especially in the intensive care unit (ICU). Morbid obesity adversely affects physiology; restricted thoracic movement and increased intra-abdominal pressure leads to reduced lung volumes and compliance resulting frequently in atelectasis, ventilation-perfusion mismatch. Cardiac surgical patients are at particular risk for PPCs. The use of cardiopulmonary bypass (CPB) is responsible for a systemic inflammatory response and oxidative stress, leading to pulmonary ischemia-reperfusion injury. Mechanical ventilation frequently is disrupted during CPB, thus inducing atelectasis. Some proposed mechanisms are leukocyte activation, fluid accumulation in the lung and atelectasis. Atelectasis is a highly prevalent pulmonary complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and an important cause of postoperative hypoxemia. Pulmonary collapse occurs early after the induction of anesthesia and persists for several days postoperatively. Studies based on thoracic computed tomography (CT) have shown that pulmonary collapse is mainly distributed to the dependent regions close to the diaphragm and may encompass up to 35% of the overall lung parenchyma which predispose to pneumonia. This impairment of lung function, particularly oxygenation of the blood, is a common and potentially serious complication after cardiac surgery. It has been shown to persist for as long as one week after the operation. In obese patients, the functional residual capacity (FRC) and lung compliance are reduced, and thus the elastic work of breathing (WOB) is elevated. By applying continuous positive airway pressure (CPAP), the FRC is restored, and inspiration starts from a more favorable pressure-volume relationship, facilitating spontaneous ventilation, and improves oxygenation. APRV was originally described as a mode to treat acute lung injury in patients and attempt to maintain the level of airway pressure without reducing cardiac function, delivering mechanical breaths without excessive airway pressure and allowing unrestricted spontaneous ventilation. 6 APRV is essentially a high-level continuous positive airway pressure (CPAP) mode that is terminated for a very brief period of time. It is this short release period that allows carbon dioxide to be cleared. The lengthy time during which the high-level CPAP is present results in substantial recruitment of alveoli of markedly different regional time constants, at rather low gas flow rates and lower airway pressures. The establishment of intrinsic PEEP by the short release time enhances oxygenation. Carbon dioxide clearance is aided by recruitment of the patient's lung at close to total lung capacity; elastic recoil creates large volume gas flow during the release period. Recent advances in the understanding of the respiratory physiologic alterations in the obese patient suggest that ''open lung'' ventilation approaches such as APRV recruit lung alveolar volumes without exacerbating lung injury and maintain acceptable gas exchange. Given the spontaneous nature of the mode, it is hypothesized that there should be no need for continuous infusions of neuromuscular blocking agents in patients placed on this mode of ventilation. This may result in a shorter duration of intensive care unit (ICU) stay. Furthermore, because patients may be ventilated at lower airway pressures than are required with cyclic ventilation, there may be a reduced need for pressor support of hemodynamics to ensure oxygen delivery which is favorable in cardiac surgical patients. So, the investigators hypothesize that APRV may be a preferred mode of ventilation in morbidly obese patients after cardiac surgery.

Official Title
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Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes

Conditions
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Pulmonary Atelectasis, Morbid Obesity, Pulmonary Complication

Intervention / Treatment
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* Device: Use Of APRV mode of Ventilation
* Device: Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 y. Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump. Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m². Exclusion Criteria: Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease). Pneumothorax or Surgical emphysema. Mechanical ventilation prior to the operation. Patient Refusal.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: APRV group<br>Group A: APRV group (30 Patients) Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15 P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O T high at 4-6 seconds P low at 0 T low at 0.5 to 0.8 seconds. ATC (automatic tube compensation) on. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation. | Device: Use Of APRV mode of Ventilation<br>* Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15 P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O T high at 4-6 seconds P low at 0 T low at 0.5 to 0.8 seconds. ATC (automatic tube compensation) on. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.<br>|
| Active Comparator: Standard group<br>Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16 Tidal Volume 6-8 ml/kg predicted body weight Respiratory rate (RR) 14 /min Positive end expiratory pressure (PEEP)= 5 cmH2o Pressure Support (PS) = 10 cmH2o Inspiratory time 1.4 Sec FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % | Device: Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode<br>* Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16 Tidal Volume 6-8 ml/kg predicted body weight Respiratory rate (RR) 14 /min Positive end expiratory pressure (PEEP)= 5 cmH2o Pressure Support (PS) = 10 cmH2o Inspiratory time 1.4 Sec FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 > 60 mmhg on FIO2 < 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of mechanical ventilation will be done by switching the ventilation to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PO2/FIO2 (P/F) ratio | Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours | up to 3 days | 
| Time of mechanical ventilation | Hours of Mechanical ventilation | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Non-Invasive ventilation (NIV) | Need of high flow nasal cannula (HFNC) or Non-Invasive continuous positive airway pressure (NICPAP) | up to 3 days | 
| Occurrence Respiratory complications | Occurrence of Pneumonia identified by clinical signs, chest Xray and lung ultrasound | up to 1 week | 
| Effect on Blood pressure | Mean arterial systemic blood pressure (MAP) recorded at admission, 6 hours, 12 hours and 24 hours | up to 1 day | 
| Need for Vasopressors and Inotropes | Vasopressors and Inotropes needs guided by Vasoactive-Inotrope score (VIS) measured at admission, 6 hours, 12 hours and 24 hours | up to 1 day | 
| length of ICU stay | Duration of patient stays in ICU in days | up to 3 days | 
| length of Hospital stay | Duration of hospital stay after surgery in days. | up to 10 days | 
| Mortality | Post operative Death | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APRV, Morbid Obesity, Cardiac surgery, Pulmonary Complications