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

NCT04082377 | Completed DMC

• 1 other identifier: MD/19.06.188
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Recruitment

Outcome Measures

Primary Outcomes (1)

• Cardiac stroke volume

  Change in the stroke volume alteration by less than 10- 20% % during recruitment maneuver in anesthesia for laproscopic surgery.

  During intra-operative mechanical ventilation time

Secondary Outcomes (6)

• Dynamic lung compliance

  During intra-operative mechanical ventilation time

• Intraoperative oxygenation

  During intra-operative mechanical ventilation time

• Horowitz ratio (Pao2/Fio2)

  During intra-operative mechanical ventilation time

• Alveolar dead space ratio

  During intra-operative mechanical ventilation time

• Mean arterial blood pressure

  During intra-operative mechanical ventilation time

Study Arms (2)

Recruitment maneuver with tidal volume (RM TV)

EXPERIMENTAL

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)

Recruitment maneuver by PEEP (RM PEEP)

ACTIVE COMPARATOR

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)

Interventions

Recruitment maneuver with tidal volume (RM TV) PROCEDURE

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.

Recruitment maneuver with tidal volume (RM TV)

Recruitment maneuver by PEEP (RM PEEP) PROCEDURE

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

Recruitment maneuver by PEEP (RM PEEP)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Dakahlia Governorate, 05022022225, Egypt

Location

MeSH Terms

Interventions

Tidal Volume

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Mahmoud M Othman, MD

  Faculty of medicine,Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The management was 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Anesthesia and surgical ICU

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 5, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)