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

NCT03776292 | Completed

• 1 other identifier: R.18.11.337
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardio-pulmonary

Keywords

cardiac, output, pulmonary, compliance, bladder, Retractor.

Outcome Measures

Primary Outcomes (2)

• -non invasive Dynamic pulmonary compliance .

  dynamic pulmonary compliance during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups

  mean dynamic compliance at minutes 30,60,90,120,180,210 240 post retractor application compared to mean dynamic compliance at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)

• Non invasive Cardiac Index

  Cardiac index monitoring during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups

  mean Non invasive Cardiac Index at minutes 30,60,90,120,180,210 240 post retractor application compared to mean Non invasive Cardiac Index at minutes 10,20,30,post endotracheal intubation(Basal Value preretractor application)

Secondary Outcomes (10)

• Static lung compliance

  After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes

• Cardiac output.

  After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes

• Stroke volume SV

  After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes

• - stroke volume variability (SVV)

  After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes

• -Cardiac performance index CPI

  After endotracheal intubation recorded 3 times every 10 minutes -After Abdominal retractors application recorded every 30 minutes for 6 readings -After retractor removal 3 times every 10 minutes

Study Arms (2)

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

Other: monitoring

lateral position group = Group (L)

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

Other: monitoring

Interventions

monitoring 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); supine position group= Group (S)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

-Patients admitted to the Urology Department, Mansoura Urology and Nephrology center, Faculty of medicine Mansoura University .

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of Medicine- Mansoura Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohamed A. Ghanem, A professor

  Mansoura Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor os anesthesia ICU & Pain medicine.

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 14, 2018
• Study Start: December 15, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

EG (1)