Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

NCT05508997 | Completed DMC

• 1 other identifier: P.T.REC/012/001827
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP\& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) \& mean arterial blood pressure (MAP) were recorded.

Conditions

Obesity Associated Disorder

Keywords

Positive end-expiratory pressure titration; Mechanical ventilator; respiratory and hemodynamics parameters; Obese patients; Reverse Trendelenburg Position.

Outcome Measures

Primary Outcomes (1)

• Respiratory parameters

  The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio

  Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.

Secondary Outcomes (1)

• Hemodynamics parameters

  Immediately after the procedure is done in the operating room appears on the patient's monitor.

Study Arms (2)

Positive End Expiatory Pressure + Reverse Trendelenburg Position

EXPERIMENTAL

Group A received the procedures of the physiotherapy part by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), which is the patient laid supine with the head up 30 degrees higher than the feet \& received the recruitment maneuver (RM) by Positive End Expiratory Pressure (PEEP) titration

Device: respiratory parameters on mechanical ventilator (PEEP)

Reverse Trendelenburg Position

ACTIVE COMPARATOR

Group B received only the procedures of the physiotherapy part at the 3rd phase of operation by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), in which the patient laid supine with the head at 15-30 degrees higher than the feet to unload the weight of intra-abdominal contents from the diaphragm, this position: 1. Increase pulmonary compliance, functional residual capacity (FRC), and oxygenation. 2. Allows easier ventilation. 3. This position called safe apnea time allows time to secure the airway before desaturation for a 20-minute positioning time.

Device: respiratory parameters on mechanical ventilator (PEEP)

Interventions

respiratory parameters on mechanical ventilator (PEEP) DEVICE

The 3rd \& 4th phases of operation in the group (A) and (B): Each patient received one single session inside the Operation Room (OR) as one shot of the treatment procedure. Arterial Blood Gases (ABGs) were obtained to measure: 1. Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome. 2. Secondary outcome. * Ventilation by PaCO2 value from ABGs. * Static compliance (Cstat) was measured as the amount of recruitment of alveoli in the lung. * Blood pressure (systolic/diastolic) one of the hemodynamics measurements was measured pre/post the procedure in the two groups.

Positive End Expiatory Pressure + Reverse Trendelenburg Position; Reverse Trendelenburg Position

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects included in this study had the following criteria:
• Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
• Obese patients with BMI (30-34.9).
• Age 40-50 years old.
• Both sexes.
• Non-smoker.
• No history of disease affecting the heart \& lungs.

You may not qualify if:

• Subjects with any of the following were excluded from the study:
• Severe head injury.
• Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
• Acute pulmonary edema.
• Barotrauma/volutrauma.
• Un-drained Pneumothorax/Hemothorax.
• Flail chest.
• Low blood pressure (systolic less than 80 mmHg).
• Oxygen saturation is less than 90%.

Sponsors & Collaborators

• Heidy F. Ahmed: lead

Study Sites (1)

Al Kasr Al Aini Teaching Hospital

Giza, 12556, Egypt

Location

Related Publications (23)

• Hibbert KA, Malhotra A. Obesity in Critically Ill Patients. In Cardiopulmonary Monitoring. 2021 (pp. 935-947). Springer, Cham. https://doi.org/10.1007/978-3-030-73387-2

  BACKGROUND

• Wang QY, Ji YW, An LX, Cao L, Xue FS. Effects of individualized PEEP obtained by two different titration methods on postoperative atelectasis in obese patients: study protocol for a randomized controlled trial. Trials. 2021 Oct 15;22(1):704. doi: 10.1186/s13063-021-05671-1.

  PMID: 34654446 BACKGROUND

• Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Muller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.

  PMID: 28454590 BACKGROUND

• Ruszkai Z, Kiss E, Laszlo I, Bokretas GP, Vizseralek D, Vamossy I, Surany E, Buzogany I, Bajory Z, Molnar Z. Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial. J Clin Monit Comput. 2021 May;35(3):469-482. doi: 10.1007/s10877-020-00519-6. Epub 2020 May 9.

  PMID: 32388650 BACKGROUND

• Silva PL, Pelosi P, Rocco PR. Ventilation in the Obese Patient. In Mechanical Ventilation from Pathophysiology to Clinical Evidence. 2022 (pp. 223-229). Springer, Cham. http://doi.org/10.1007/978-3-030-93401-9

  BACKGROUND

• Bruins S, Sommerfield D, Powers N, von Ungern-Sternberg BS. Atelectasis and lung recruitment in pediatric anesthesia: An educational review. Paediatr Anaesth. 2022 Feb;32(2):321-329. doi: 10.1111/pan.14335. Epub 2021 Nov 24.

  PMID: 34797011 BACKGROUND

• Brodsky JB. Recent advances in anesthesia of the obese patient. F1000Res. 2018 Aug 6;7:F1000 Faculty Rev-1195. doi: 10.12688/f1000research.15093.1. eCollection 2018.

  PMID: 30135720 BACKGROUND

• De Jong A, Wrigge H, Hedenstierna G, Gattinoni L, Chiumello D, Frat JP, Ball L, Schetz M, Pickkers P, Jaber S. How to ventilate obese patients in the ICU. Intensive Care Med. 2020 Dec;46(12):2423-2435. doi: 10.1007/s00134-020-06286-x. Epub 2020 Oct 23.

  PMID: 33095284 BACKGROUND

• Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.

  PMID: 33137453 BACKGROUND

• Boone MD, Jinadasa SP, Mueller A, Shaefi S, Kasper EM, Hanafy KA, O'Gara BP, Talmor DS. The Effect of Positive End-Expiratory Pressure on Intracranial Pressure and Cerebral Hemodynamics. Neurocrit Care. 2017 Apr;26(2):174-181. doi: 10.1007/s12028-016-0328-9.

  PMID: 27848125 BACKGROUND

• Fumagalli J, Santiago RRS, Teggia Droghi M, Zhang C, Fintelmann FJ, Troschel FM, Morais CCA, Amato MBP, Kacmarek RM, Berra L; Lung Rescue Team Investigators. Lung Recruitment in Obese Patients with Acute Respiratory Distress Syndrome. Anesthesiology. 2019 May;130(5):791-803. doi: 10.1097/ALN.0000000000002638.

  PMID: 30844949 BACKGROUND

• Zhu C, Yao JW, An LX, Bai YF, Li WJ. Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial. Trials. 2020 Jul 6;21(1):618. doi: 10.1186/s13063-020-04565-y.

  PMID: 32631414 BACKGROUND

• Eichler L, Truskowska K, Dupree A, Busch P, Goetz AE, Zollner C. Intraoperative Ventilation of Morbidly Obese Patients Guided by Transpulmonary Pressure. Obes Surg. 2018 Jan;28(1):122-129. doi: 10.1007/s11695-017-2794-3.

  PMID: 28707173 RESULT

• Lutfi MF. The physiological basis and clinical significance of lung volume measurements. Multidiscip Respir Med. 2017 Feb 9;12:3. doi: 10.1186/s40248-017-0084-5. eCollection 2017.

  PMID: 28194273 RESULT

• Moon TS, Tai K, Kim A, Gonzales MX, Lu R, Pak T, Smith K, Chen JL, Minhajuddin AT, Nnamani N, Fox PE, Ogunnaike B. Apneic Oxygenation During Prolonged Laryngoscopy in Obese Patients: a Randomized, Double-Blinded, Controlled Trial of Nasal Cannula Oxygen Administration. Obes Surg. 2019 Dec;29(12):3992-3999. doi: 10.1007/s11695-019-04077-y.

  PMID: 31317460 RESULT

• Simon P, Girrbach F, Petroff D, Schliewe N, Hempel G, Lange M, Bluth T, Gama de Abreu M, Beda A, Schultz MJ, Pelosi P, Reske AW, Wrigge H; PROBESE Investigators of the Protective Ventilation Network* and the Clinical Trial Network of the European Society of Anesthesiology. Individualized versus Fixed Positive End-expiratory Pressure for Intraoperative Mechanical Ventilation in Obese Patients: A Secondary Analysis. Anesthesiology. 2021 Jun 1;134(6):887-900. doi: 10.1097/ALN.0000000000003762.

  PMID: 33843980 RESULT

• Hassan EA, Baraka AAE. The effect of reverse Trendelenburg position versus semi-recumbent position on respiratory parameters of obese critically ill patients: A randomised controlled trial. J Clin Nurs. 2021 Apr;30(7-8):995-1002. doi: 10.1111/jocn.15645. Epub 2021 Jan 25.

  PMID: 33432600 RESULT

• Soleimanpour H, Safari S, Sanaie S, Nazari M, Alavian SM. Anesthetic Considerations in Patients Undergoing Bariatric Surgery: A Review Article. Anesth Pain Med. 2017 Jul 11;7(4):e57568. doi: 10.5812/aapm.57568. eCollection 2017 Aug.

  PMID: 29430407 RESULT

• Jonkman AH, Ranieri VM, Brochard L. Lung recruitment. Intensive Care Med. 2022 Jul;48(7):936-938. doi: 10.1007/s00134-022-06715-z. Epub 2022 May 2. No abstract available.

  PMID: 35499759 RESULT

• Gao D, Sun L, Wang N, Shi Y, Song J, Liu X, Yang Q, Su Z. Impact of 30 degrees Reserve Trendelenburg Position on Lung Function in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy. Front Surg. 2022 Feb 24;9:792697. doi: 10.3389/fsurg.2022.792697. eCollection 2022.

  PMID: 35284476 RESULT

• Ball L, Pelosi P. How I ventilate an obese patient. Crit Care. 2019 May 16;23(1):176. doi: 10.1186/s13054-019-2466-x. No abstract available.

  PMID: 31097006 RESULT

• Protti A, Santini A, Pennati F, Chiurazzi C, Cressoni M, Ferrari M, Iapichino GE, Carenzo L, Lanza E, Picardo G, Caironi P, Aliverti A, Cecconi M. Lung Response to a Higher Positive End-Expiratory Pressure in Mechanically Ventilated Patients With COVID-19. Chest. 2022 Apr;161(4):979-988. doi: 10.1016/j.chest.2021.10.012. Epub 2021 Oct 16.

  PMID: 34666011 RESULT

• Yilmaz H, Kazbek BK, Koksoy UC, Gul AM, Ekmekci P, Caglar GS, Tuzuner F. Hemodynamic outcome of different ventilation modes in laparoscopic surgery with exaggerated trendelenburg: a randomised controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):88-94. doi: 10.1016/j.bjane.2021.04.028. Epub 2021 May 12.

  PMID: 33991554 RESULT

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Heidy F. Ahmed, Master

  Kasr al aini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the patients were under general anesthesia didn't know which procedure they received \& the outcomes assessor done by my supervisors and didn't know which result related to specific group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of physical therapy at Al kasr Al Anini teaching hospital, Cairo, Egypt

Model Details: group A receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 19, 2022
• Study Start: December 1, 2021
• Primary Completion: June 17, 2022
• Study Completion: June 30, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In the next month of registration.
• Access Criteria: Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.

Locations

EG (1)