Cardiac Function Disturbance Postoperative, Manual Ventilation, Mechanical Ventilation, Oxygenation, Point of Care Ultrasound
Conditions
Keywords
ventilator, point of care ultrasound, transport
Brief summary
This is a clinical trial to compare the oxygenation and ventilation performance between manual ventilation and mechanical ventilation when transporting cardiac patients to the ICU.
Detailed description
Following cardiac surgery, patients often require ventilation during transport to the intensive care unit (ICU). Most of the time, manual ventilation using an AMBU bag (AMBU INC. MD, USA) is utilized, but some patients need mechanical ventilation due to concern for oxygenation, ventilation, and hemodynamics. The indication to choose mechanical ventilation over manual ventilation is determined on a case-by-case basis, mostly based on providers' experiences or surgical request, because currently there is no clear clinical evidence behind that. With this clinical study, the investigators intend to build up clinical evidence by comparing oxygenation, ventilation, hemodynamics, and cardiac functions between two arms: manual ventilation using AMBU bag arm and mechanical ventilation using a transport ventilator. Objective: In this study, the investigators plan to compare the effects of transport ventilators (Hamilton C1: Bodaduz, Schweiz) and AMBU bag manual ventilation on oxygenation, ventilation, biventricular function, and hemodynamics. This is a two-arm study. 1. To assess pre and post transport PaO2/FiO2 (P/F ratio), PaCO2, biventricular function, and mean artery pressure in the AMBU bag and Hamilton transport ventilator groups. The investigators hypothesize that using the Hamilton transport ventilator will show a smaller change in P/F ratio, mean artery blood pressures and biventricular function compared to the AMBU bag group. If true, these findings would support using the Hamilton ventilator for transport in appropriate surgical patients. 2. To perform "in-vitro" flow analysis using a flow analyzer analyzer (CITREX H5: Buchs, Schweiz) and lung simulator (SmartLung 2000: Buchs, Schweiz) to measure the accuracy of the ventilations of Hamilton C1 ventilator and AMBU bag manual ventilation on different resistance and compliance settings of the lung simulator
Interventions
DEVICEHamilton C1 ventilator during transport to the ICU
Instead of AMBU bag manual ventilation during transport to the ICU, intervention is using Hamilton C1 ventilator during transport to the ICU
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Masking description
The patients will be randomly assigned to 2 arms above and the patients are not informed about which arm they are assigned.
Intervention model description
After IRB approval and obtaining a written informed consent, patients will be randomly assigned to the one of the following 2 arms. However, AMBU bag arm patients may be switched to Hamilton C1 at an anesthesia provider's discretion based on post cardiopulmonary bypass right ventricular function, PaO2/FiO2, and PaCO2. These patients will be excluded from the AMBU bag arm. Arm 1: AMBU bag manual ventilation during transport to the ICU Arm 2: Hamilton C1 ventilator during transport to the ICU
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old (any gender or race) * Cardiac surgery * Require postoperative mechanical ventilation and care in the ICU.
Exclusion criteria
* Patients' refusal * Extubation in OR * On mechanical circulatory support * Requirement for postoperative therapy with inhaled pulmonary vasodilators (epoprostenol (FLOLAN), inhaled nitric oxide, etc.) * Severe RV dysfunction with preoperative echocardiography * Contraindication to TEE and pulmonary artery catheter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The % Change in Mean Artery Blood Pressure | Pre-transport hemodynamic values were averaged from the final three readings (taken at 1-min intervals) before switching to the transport monitor, and post-transport readings were recorded immediately after transfer to the ICU monitor. | The % change in mean artery blood pressure before and after the transport to the ICU. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The % Changes in PaO2/FiO2 (P/F Ratio) | First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment. | The % changes in PaO2/FiO2 (P/F ratio) pre and post transport to ICU. P/F ratio will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%) |
| The % Change in PaCO2 | First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment. | The % changes in PaCO2 pre and post transport to ICU. PaCO2 will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%) |
| The Visual Scale in Changes in Left Ventricular Function | First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment. | Within-group and between-group changes in visual assessment of left ventricular function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic) |
| The Visual Scale in Changes in Right Ventricular Function | First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment. | Within-group and between-group changes in visual assessment of right ventricular cardiac function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic) |
Countries
United States
Participant flow
Recruitment details
Patient recruitment was done from November 1, 2023, to October 9, 2024. Location was a university medical center. Patients aged \> 18 years who underwent full sternotomy cardiac surgery and required postoperative ICU care were included in the study. The exclusion criteria included extubation in the operating room, postoperative need for mechanical circulatory support, postoperative open chest, and continuous inhalation of epoprostenol or nitric oxide.
Pre-assignment details
Patients who needed to be switched the ventilation method from the originally designated method were excluded from the study before assignment to the arms.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU patients who were transported to the ICU with manual (AMBU bag) ventilation | 38 |
| Arm 2: Hamilton C1 Ventilator During Transport to the ICU patients who were transported to the ICU with mechanical (Hamilton C1) ventilation | 39 |
| Total | 77 |
Baseline characteristics
| Characteristic | Arm 1: AMBU Bag Manual Ventilation During Transport to the ICU | Arm 2: Hamilton C1 Ventilator During Transport to the ICU | Total |
|---|---|---|---|
| Age, Continuous | 61.42 years old STANDARD_DEVIATION 130.8 | 66.92 years old STANDARD_DEVIATION 8.83 | 64.2 years old STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 38 Participants | 67 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 39 |
| other Total, other adverse events | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
Primary
The % Change in Mean Artery Blood Pressure
The % change in mean artery blood pressure before and after the transport to the ICU. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Time frame: Pre-transport hemodynamic values were averaged from the final three readings (taken at 1-min intervals) before switching to the transport monitor, and post-transport readings were recorded immediately after transfer to the ICU monitor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | The % Change in Mean Artery Blood Pressure | -3.73 % change in mean artery pressure | Standard Deviation 18.04 |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | The % Change in Mean Artery Blood Pressure | 13 % change in mean artery pressure | Standard Deviation 15.61 |
Secondary
The % Change in PaCO2
The % changes in PaCO2 pre and post transport to ICU. PaCO2 will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | The % Change in PaCO2 | 3.42 The percent change in PaCO2 |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | The % Change in PaCO2 | 3.06 The percent change in PaCO2 |
p-value: 0.891Wilcoxon (Mann-Whitney)
Secondary
The % Changes in PaO2/FiO2 (P/F Ratio)
The % changes in PaO2/FiO2 (P/F ratio) pre and post transport to ICU. P/F ratio will be assessed on arterial blood gas immediately before and after the transport to ICU, at the same time as the investigators do echocardiographic assessment as described above. i.e. (post-transport measurement - pre-transport measurement)/pre-transport measurement x100 (%)
Time frame: First aortic blood gas analysis Immediately before transport to ICU till the second arterial blood gas analysis after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | The % Changes in PaO2/FiO2 (P/F Ratio) | 6.76 The percent change in PF ratio |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | The % Changes in PaO2/FiO2 (P/F Ratio) | -12.2 The percent change in PF ratio |
p-value: 0.275Wilcoxon (Mann-Whitney)
Secondary
The Visual Scale in Changes in Left Ventricular Function
Within-group and between-group changes in visual assessment of left ventricular function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
Time frame: First visual assessment of left ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
Population: The number of participants who had a change in visual assessment of left ventricular function pre and post-transport
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | The Visual Scale in Changes in Left Ventricular Function | 0 Participants |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | The Visual Scale in Changes in Left Ventricular Function | 0 Participants |
Secondary
The Visual Scale in Changes in Right Ventricular Function
Within-group and between-group changes in visual assessment of right ventricular cardiac function parameters before and after transport (1: severe hypokinetic, 2: moderate hypokinetic, 3: mild hypokinetic, 4: normal, 5: hyperdynamic)
Time frame: First visual assessment of right ventricular function Immediately before transport to ICU till the second visual assessment after dropping off the patient at ICU; approximately 30 minutes after the first visual assessment.
Population: The number of participants who had a change in visual assessment of right ventricular function pre and post-transport
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: AMBU bag manual ventilation during transport to the ICU | The Visual Scale in Changes in Right Ventricular Function | 0 Participants |
| Arm 2: Hamilton C1 ventilator during transport to the ICU | The Visual Scale in Changes in Right Ventricular Function | 0 Participants |