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Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Laproscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082377
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Othman, Mansoura University

Brief Summary:
Pneumoperitoneum with CO2 insufflation during laparoscopic surgery elevates the intrathoracic pressure through the elevation of the diaphragm, which in turn decreases the lung compliance .Alveolar recruitment (AR) refers to the dynamic process of opening collapsed lung units by increasing transpulmonary pressure. It increases the area of ventilated lung parenchyma, thus improving gas exchange and arterial oxygenation .During lung recruitment, a transient increase in transpulmonary pressure induced by an intentional increase in airway pressures, results in an increase in intrathoracic pressure and a decrease in venous return, leading to a decrease in left ventricular end-diastolic areas and in stroke volume.

Condition or disease Intervention/treatment Phase
Recruitment Procedure: Recruitment maneuver with tidal volume (RM TV) Procedure: Recruitment maneuver by PEEP (RM PEEP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The management will be carried out by a member of research team only aware of allocation group. The participants ,outcome assessor, surgeons and nursing staff will be totally blind of randomization schedule. All postoperative clinical staff handling patient care will be also unaware of the aim of the work.
Primary Purpose: Supportive Care
Official Title: Effects of Two Different Stepwise Lung Recruitment Maneuvers on Patient Hemodynamics During Anesthesia for Laproscopic Surgery
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: Recruitment maneuver with tidal volume (RM TV)
RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW ,RR at 7 breaths/min, PEEP at 5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM. The ventilation protocol could be changed at any time when concerned about patient safety.
Procedure: Recruitment maneuver with tidal volume (RM TV)

The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.

RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) Brower, et al. 1999, RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM.


Active Comparator: Recruitment maneuver by PEEP (RM PEEP)

The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia 5 cmH2O PEEP.

RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver.

Procedure: Recruitment maneuver by PEEP (RM PEEP)
The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, in RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver




Primary Outcome Measures :
  1. Cardiac stroke volume [ Time Frame: During intra-operative mechanical ventilation time ]
    Change in the stroke volume alteration by less than 10- 20% % during recruitment maneuver in anesthesia for laproscopic surgery.


Secondary Outcome Measures :
  1. Dynamic lung compliance [ Time Frame: During intra-operative mechanical ventilation time ]
    Change of dynamic lung compliance by more than 20% above basal.

  2. Intraoperative oxygenation [ Time Frame: During intra-operative mechanical ventilation time ]
    Change of intraoperative oxygenation with oxygen delivery index more than 550 ml/min/m2.

  3. Horowitz ratio (Pao2/Fio2) [ Time Frame: During intra-operative mechanical ventilation time ]
    Change of intraoperative oxygenation with Horowitz ratio more than 350.

  4. Alveolar dead space ratio [ Time Frame: During intra-operative mechanical ventilation time ]
    Change of the calculated alveolar dead space ratio (vd/vt) by less than 15%.

  5. Mean arterial blood pressure [ Time Frame: During intra-operative mechanical ventilation time ]
    Maintain mean blood pressure not less than 60 mmHg.

  6. Pulmonary complications [ Time Frame: During first 2 hours postoperative period ]
    Number of patients with postoperative pulmonary complications like atelectasis or pneumothorax.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients with American Society of Anesthesiologists (ASA) physical status I - II .
  2. Both sexes.
  3. laproscopic surgeries.

Exclusion Criteria :

  1. Patients younger than 20 years.
  2. body mass index (BMI) < 25 and > 35.
  3. patients with major cardiovascular problems with ejection fraction < 40 %.
  4. patients with chronic obstructive pulmonary diseases.
  5. patients with major hepatic or renal dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082377


Contacts
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Contact: Mahmoud M Othman, MD 00201006278070 mmothman59@hotmail.com
Contact: Sherif F Hassan, Msc 00201014148715 mmothman59@hotmail.com

Locations
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Egypt
Urology and nephrology center Recruiting
Mansoura, El-Dakahlia, Egypt, 05022022225
Contact: Mahmoud M Othman, MD    01006278070    mmothman59@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mahmoud M Othman, MD Faculty of medicine,Mansoura University
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Responsible Party: Mahmoud Othman, professor of Anesthesia and surgical ICU, Mansoura University
ClinicalTrials.gov Identifier: NCT04082377    
Other Study ID Numbers: MD/19.06.188
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No