Cardiopulmonary Changes Prolonged Surgical Abdominal Retractors Application in Supine Versus Lateral Position

NCT ID: NCT03776292

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2019-03-30

Brief Summary

Introduction: Dynamic and static compliance should be calculated as a routine part of ventilator monitoring. Dynamic and static compliance are 60-100 mL/cm H2O. A decrease in dynamic compliance without a change in the static compliance suggests an acute increase in airway resistance and can be assessed further by comparing peak pressure and plateau pressure. The normal gradient is approximately 10 cm H2O. A gradient >10 cm H2O may be secondary to endotracheal tube obstruction, mucous plugging, or bronchospasm. If volume is constant, acute changes in both dynamic and static compliance suggest a decrease in respiratory system compliance that may be caused by worsening increasing abdominal pressures. When static compliance is <25 mL/cm H2O, ventilator weaning may be difficult secondary to tachypnea during spontaneous breathing trials. (1) Aim of the work: to detect the cardiopulmonary burden of surgical ring retractors application during abdominal surgeries in supine versus lateral position (cancer bladder for supine position and open surgical nephrectomy for lateral position). Hypothesis: Abdominal retractors application would produce more cardiopulmonary instability during lateral position than during supine position for abdominal surgery. Patient & Methods: This comparative prospective randomized study, will be done on ASA I-II patients, both sexes, Age 18 - 65 year, to compare pulmonary compliance and cardiac performance before, during and after surgical self-retaining abdominal retractors application patients will be divided into 2 groups; 1st group (S) will undergo orthotropic cancer bladder diversion and the 2nd group (L) both supine and lateral position for open surgical nephrectomy for lateral position.

Detailed Description

Introduction: Dynamic and static compliance should be calculated as a routine part of ventilator monitoring. Dynamic and static compliance are 60-100 mL/cm H2O. A decrease in dynamic compliance without a change in the static compliance suggests an acute increase in airway resistance and can be assessed further by comparing peak pressure and plateau pressure. The normal gradient is approximately 10 cm H2O. A gradient >10 cm H2O may be secondary to endotracheal tube obstruction, mucous plugging, or bronchospasm. If volume is constant, acute changes in both dynamic and static compliance suggest a decrease in respiratory system compliance that may be caused by worsening increasing abdominal pressures. When static compliance is <25 mL/cm H2O, ventilator weaning may be difficult secondary to tachypnea during spontaneous breathing trials. (1) Aim of the work: to detect the cardiopulmonary burden of surgical ring retractors application during abdominal surgeries in supine versus lateral position (cancer bladder for supine position and open surgical nephrectomy for lateral position). Hypothesis: Abdominal retractors application would produce more cardiopulmonary instability during lateral position than during supine position for abdominal surgery. Patient & Methods: This comparative prospective randomized study, will be done on ASA I-II patients, both sexes, Age 18 - 65 year, to compare pulmonary compliance and cardiac performance before, during and after surgical self-retaining abdominal retractors application patients will be divided into 2 groups; 1st group (S) will undergo orthotropic cancer bladder diversion and the 2nd group (L) both supine and lateral position for open surgical nephrectomy for lateral position. Study will be done at Mansoura University Hospital, during the year 2018, for 4 month duration, starting predected date=1-11-2018 actual study start date=15-12-2018[ NB. by mistake in the 1st registration i have regestered the study protocol predicted time of study start but actually the study started on 15-12-2018 thats why i changed the date more than one time ] till 30-3-2019 after approval of IRB (Institutional Review Board), Mansoura Faculty of Medicine. Primary outcome; composite 1ry outcome [1-Dynamic pulmonary compliance.2- Cardiac Index] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups. Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index CPI, O2 delivery DIO2. Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.

Conditions

Cardio-pulmonary

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

supine position group= Group (S)

1st group of 20 patients will undergo urinary bladder cystectomy and orthotopic urinary diversion lying supine with ring abdominal retractors

monitoring

Intervention Type: OTHER

Primary outcome; composite 1ry outcome \[1-Dynamic pulmonary compliance monitoring.2- Cardiac Index monitoring\] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups. Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2. Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)\] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.

lateral position group = Group (L)

2nd group of 20 patients will undergo surgical open nephrectomy lying lateral position with self retaining abdominal retractors

monitoring

Intervention Type: OTHER

Primary outcome; composite 1ry outcome \[1-Dynamic pulmonary compliance monitoring.2- Cardiac Index monitoring\] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups. Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2. Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)\] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.

Interventions

monitoring

Primary outcome; composite 1ry outcome \[1-Dynamic pulmonary compliance monitoring.2- Cardiac Index monitoring\] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups. Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2. Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)\] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ASA I-II patients
• both sexes
• Age 18 - 65 year
• surgical time ≥ 6hours for Orthotopic urinary bladder diversion surgery for cancer bladder patients and 3 hours for open surgical nephrectomy.

Exclusion Criteria

• Body mass index (BMI) greater than 35 kg. m-2.
• Asthma requiring bronchodilator therapy.
• Chronic Obstructive Pulmonary Disease, GOLD classification III and IV.
• Severe pulmonary disease.
• Hemodynamic instability (hypotension or tachycardia).
• History of congestive heart failure or New York Heart Association (NYHA) functional class IV
• Right ventricular dysfunction.
• Severe valvular heart disease.
• Intra-cardiac shunts.
• Intracranial hypertension.
• Cardiac rhythm other than regular sinus.
• Severe chronic kidney disease (glomerular filtration rate < 30 ml. min-1. 1.73 m2).
• Liver cirrhosis (Child Pugh class B or C).
• Pregnancy.
• Previous thoracic surgery (lobectomy, bilobectomy, or pneumonectomy).
• Lung metastatic surgery.
• Previous receiving chemotherapy.
• Emergency surgery.
• Preoperative need for invasive mechanical ventilation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abd Latif Ghanim

Associate Professor os anesthesia ICU & Pain medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A. Ghanem, A professor

Role: PRINCIPAL_INVESTIGATOR

Mansoura Univeristy

Locations

Mansoura faculty of Medicine- Mansoura Urology and nephrology center

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

R.18.11.337

Identifier Type: -

Identifier Source: org_study_id