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

Primary Purpose

Pulmonary Atelectasis, Morbid Obesity, Pulmonary Complication

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Use Of APRV mode of Ventilation
Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Atelectasis focused on measuring APRV, Morbid Obesity, Cardiac surgery, Pulmonary Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiothoracic Academy, Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

APRV group

Standard group

Arm Description

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.

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 %

Outcomes

Primary Outcome Measures

PO2/FIO2 (P/F) ratio
Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours
Time of mechanical ventilation
Hours of Mechanical ventilation

Secondary Outcome Measures

Need for Non-Invasive ventilation (NIV)
Need of high flow nasal cannula (HFNC) or Non-Invasive continuous positive airway pressure (NICPAP)
Occurrence Respiratory complications
Occurrence of Pneumonia identified by clinical signs, chest Xray and lung ultrasound
Effect on Blood pressure
Mean arterial systemic blood pressure (MAP) recorded at admission, 6 hours, 12 hours and 24 hours
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
length of ICU stay
Duration of patient stays in ICU in days
length of Hospital stay
Duration of hospital stay after surgery in days.
Mortality
Post operative Death

Full Information

First Posted
December 8, 2022
Last Updated
December 30, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05670483
Brief Title
Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery
Official Title
Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2022 (Actual)
Primary Completion Date
May 3, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis, Morbid Obesity, Pulmonary Complication
Keywords
APRV, Morbid Obesity, Cardiac surgery, Pulmonary Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APRV group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard group
Arm Type
Active Comparator
Arm Description
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 %
Intervention Type
Device
Intervention Name(s)
Use Of APRV mode of Ventilation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode
Intervention Description
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.
Primary Outcome Measure Information:
Title
PO2/FIO2 (P/F) ratio
Description
Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours
Time Frame
up to 3 days
Title
Time of mechanical ventilation
Description
Hours of Mechanical ventilation
Time Frame
up to 3 days
Secondary Outcome Measure Information:
Title
Need for Non-Invasive ventilation (NIV)
Description
Need of high flow nasal cannula (HFNC) or Non-Invasive continuous positive airway pressure (NICPAP)
Time Frame
up to 3 days
Title
Occurrence Respiratory complications
Description
Occurrence of Pneumonia identified by clinical signs, chest Xray and lung ultrasound
Time Frame
up to 1 week
Title
Effect on Blood pressure
Description
Mean arterial systemic blood pressure (MAP) recorded at admission, 6 hours, 12 hours and 24 hours
Time Frame
up to 1 day
Title
Need for Vasopressors and Inotropes
Description
Vasopressors and Inotropes needs guided by Vasoactive-Inotrope score (VIS) measured at admission, 6 hours, 12 hours and 24 hours
Time Frame
up to 1 day
Title
length of ICU stay
Description
Duration of patient stays in ICU in days
Time Frame
up to 3 days
Title
length of Hospital stay
Description
Duration of hospital stay after surgery in days.
Time Frame
up to 10 days
Title
Mortality
Description
Post operative Death
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A. Alhadidy, MD
Phone
+201005092648
Email
Mohamed_alaaeldin@med.asu.edu.eg
Facility Information:
Facility Name
Cardiothoracic Academy, Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
University President, MD
Phone
+2026847819
Email
gd.research@asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed A. Alhadidy, MD
First Name & Middle Initial & Last Name & Degree
Mohamed M. Ellewa, MD
First Name & Middle Initial & Last Name & Degree
Ahmed M. Eldemerdash, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery

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