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

NCT05670483 | Unknown DMC

• 1 other identifier: FMASU R 243/2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

APRV; Morbid Obesity; Cardiac surgery; Pulmonary Complications

Outcome Measures

Primary Outcomes (2)

• PO2/FIO2 (P/F) ratio

  Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours

  up to 3 days

• Time of mechanical ventilation

  Hours of Mechanical ventilation

  up to 3 days

Secondary Outcomes (7)

• Need for Non-Invasive ventilation (NIV)

  up to 3 days

• Occurrence Respiratory complications

  up to 1 week

• Effect on Blood pressure

  up to 1 day

• Need for Vasopressors and Inotropes

  up to 1 day

• length of ICU stay

  up to 3 days

Study Arms (2)

APRV group

ACTIVE COMPARATOR

Group A: APRV group (30 Patients) 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 APRV mode of Ventilation

Standard group

ACTIVE COMPARATOR

Group B: Standard (control) group (30 Patients) 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 %

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

Interventions

Use Of APRV mode of Ventilation DEVICE

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.

APRV group

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

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.

Standard group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 y.
• Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
• Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m².

You may not qualify if:

• Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease).
• Pneumothorax or Surgical emphysema.
• Mechanical ventilation prior to the operation.
• Patient Refusal.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Cardiothoracic Academy, Ain Shams University Hospitals

Cairo, 11566, Egypt

RECRUITING

Related Publications (15)

• Villavicencio MA, Sundt TM 3rd, Daly RC, Dearani JA, McGregor CG, Mullany CJ, Orszulak TA, Puga FJ, Schaff HV. Cardiac surgery in patients with body mass index of 50 or greater. Ann Thorac Surg. 2007 Apr;83(4):1403-11. doi: 10.1016/j.athoracsur.2006.10.076.

  PMID: 17383347 BACKGROUND

• Ranucci M, Ballotta A, La Rovere MT, Castelvecchio S; Surgical and Clinical Outcome Research (SCORE) Group. Postoperative hypoxia and length of intensive care unit stay after cardiac surgery: the underweight paradox? PLoS One. 2014 Apr 7;9(4):e93992. doi: 10.1371/journal.pone.0093992. eCollection 2014.

  PMID: 24709952 BACKGROUND

• Neves FH, Carmona MJ, Auler JO Jr, Rodrigues RR, Rouby JJ, Malbouisson LM. Cardiac compression of lung lower lobes after coronary artery bypass graft with cardiopulmonary bypass. PLoS One. 2013 Nov 11;8(11):e78643. doi: 10.1371/journal.pone.0078643. eCollection 2013.

  PMID: 24244331 BACKGROUND

• Daoud EG. Airway pressure release ventilation. Ann Thorac Med. 2007 Oct;2(4):176-9. doi: 10.4103/1817-1737.36556.

  PMID: 19727373 BACKGROUND

• Ge H, Lin L, Xu Y, Xu P, Duan K, Pan Q, Ying K. Airway Pressure Release Ventilation Mode Improves Circulatory and Respiratory Function in Patients After Cardiopulmonary Bypass, a Randomized Trial. Front Physiol. 2021 Jun 3;12:684927. doi: 10.3389/fphys.2021.684927. eCollection 2021.

  PMID: 34149459 BACKGROUND

• Testerman GM, Breitman I, Hensley S. Airway pressure release ventilation in morbidly obese surgical patients with acute lung injury and acute respiratory distress syndrome. Am Surg. 2013 Mar;79(3):242-6.

  PMID: 23461947 BACKGROUND

• Kaplan LJ, Bailey H, Formosa V. Airway pressure release ventilation increases cardiac performance in patients with acute lung injury/adult respiratory distress syndrome. Crit Care. 2001 Aug;5(4):221-6. doi: 10.1186/cc1027. Epub 2001 Jul 2.

  PMID: 11511336 BACKGROUND

• Bonatti G, Robba C, Ball L, Silva PL, Rocco PRM, Pelosi P. Controversies when using mechanical ventilation in obese patients with and without acute distress respiratory syndrome. Expert Rev Respir Med. 2019 May;13(5):471-479. doi: 10.1080/17476348.2019.1599285. Epub 2019 Apr 5.

  PMID: 30919705 BACKGROUND

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

  PMID: 31054241 BACKGROUND

• Manjunath V, Reddy BG, Prasad SR. Is airway pressure release ventilation, a better primary mode of post-operative ventilation for adult patients undergoing open heart surgery? A prospective randomised study. Ann Card Anaesth. 2021 Jul-Sep;24(3):288-293. doi: 10.4103/aca.ACA_98_20.

  PMID: 34269256 BACKGROUND

• Sawano Y, Miyazaki M, Shimada H, Kadoi Y. Optimal fentanyl dosage for attenuating systemic hemodynamic changes, hormone release and cardiac output changes during the induction of anesthesia in patients with and without hypertension: a prospective, randomized, double-blinded study. J Anesth. 2013 Aug;27(4):505-11. doi: 10.1007/s00540-012-1552-x. Epub 2013 Jan 12.

  PMID: 23314694 BACKGROUND

• Members of the Working Party; Nightingale CE, Margarson MP, Shearer E, Redman JW, Lucas DN, Cousins JM, Fox WT, Kennedy NJ, Venn PJ, Skues M, Gabbott D, Misra U, Pandit JJ, Popat MT, Griffiths R; Association of Anaesthetists of Great Britain; Ireland Society for Obesity and Bariatric Anaesthesia. Peri-operative management of the obese surgical patient 2015: Association of Anaesthetists of Great Britain and Ireland Society for Obesity and Bariatric Anaesthesia. Anaesthesia. 2015 Jul;70(7):859-76. doi: 10.1111/anae.13101. Epub 2015 May 7.

  PMID: 25950621 BACKGROUND

• Alwardt CM, Redford D, Larson DF. General anesthesia in cardiac surgery: a review of drugs and practices. J Extra Corpor Technol. 2005 Jun;37(2):227-35.

  PMID: 16117465 BACKGROUND

• Modrykamien A, Chatburn RL, Ashton RW. Airway pressure release ventilation: an alternative mode of mechanical ventilation in acute respiratory distress syndrome. Cleve Clin J Med. 2011 Feb;78(2):101-10. doi: 10.3949/ccjm.78a.10032.

  PMID: 21285342 BACKGROUND

• Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25.

  PMID: 35094928 RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis; Obesity, Morbid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed A. Alhadidy, MD

CONTACT

+201005092648; Mohamed_alaaeldin@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 4, 2023
• Study Start: December 3, 2022
• Primary Completion: May 3, 2023
• Study Completion: June 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

EG (1)