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Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery

NCT05670483 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-04

No results posted yet for this study

Summary

The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode

Conditions

  • Pulmonary Atelectasis
  • Morbid Obesity
  • Pulmonary Complication

Interventions

DEVICE

Use Of APRV mode of Ventilation

Post operatively, Patients will be ventilated with APRV mode using GE Carescape R860 ventilator Initial Settings15 1. P high at the P plateau (or desired P mean + 3cm H2O). keep P high below 30-35 cm H2O 2. T high at 4-6 seconds 3. P low at 0 4. T low at 0.5 to 0.8 seconds. 5. ATC (automatic tube compensation) on. 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 \> 60 mmhg on FIO2 \< 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of APRV will start as following, P-High will be lowered 2 or 3 cm of H2O pressure at a time, and T Low will be lengthened in 0.5-2.0 s increments, depending on patient tolerance. When the P-high reaches 10 cmH2O and the Thigh reaches 12-15 seconds, change the mode to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.

DEVICE

Use of conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode

Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode using GE Carescape R860 ventilator Initial Settings: 16 1. Tidal Volume 6-8 ml/kg predicted body weight 2. Respiratory rate (RR) 14 /min 3. Positive end expiratory pressure (PEEP)= 5 cmH2o 4. Pressure Support (PS) = 10 cmH2o 5. Inspiratory time 1.4 Sec 6. FIO2: 40% Ventilator settings will be adjusted to keep Pco2 between 35-45 mmhg, PO2 \> 60 mmhg on FIO2 \< 50 % Once Patients are fully conscious and after complete recovery of reflexes with no postoperative bleeding nor hemodynamic instability, weaning of mechanical ventilation will be done by switching the ventilation to pressure support (PS) mode PS of 7-8 cmH20 above PEEP of cmh2o then extubation.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-03
Primary Completion
2023-05-03
Completion
2023-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670483 on ClinicalTrials.gov