Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery

NCT06619626 | Recruiting

• 1 other identifier: 2023-583
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators planned to evaluate the effect of alveolar recruitment strategy primarily on postoperative pulmonary complications in obese patients undergoing lung protective ventilation in major open gynaeco-oncological surgeries. Our other aim was to evaluate perioperative haemodynamics, respiratory mechanics,inpatient length of stay.

Conditions

Gynecologic Cancers

Keywords

gynecologic cancer surgery; alveolar recruitment strategy; positive end-expiratory pressure

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  Our primary aim was to compare the presence of postoperative pulmonary complications. The presence of these pulmonary complications will be compared between preoperative chest X-ray and postoperative day 1 X-ray imaging in patients with Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score below 44.

  24 hours postoperatively

Secondary Outcomes (1)

• intraoperative haemodynamic parameters

  intraoperatively

Study Arms (2)

Group 1, lung protective ventilation with alveolar recruitment

In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, the number of breaths will be adjusted and ventilation will be started. After 10 minutes of ventilation, alveolar recruitment manoeuvre will be started by switching the mechanical ventilator to pressure controlled ventilation (PCV) mode in patients in whom alveolar recruitment strategy (ARS) will be applied. PEEP will be 30 cmHg with 2 unit increases in PEEP for 2 minutes each ventilation will be applied until PEEP reaches 20. When the mean arterial pressure decreases more than 20%, recruitment will be terminated. PEEP will be restored when PEEP 20 is reached. Mechanical ventilation will be switched to VCV mode.

Device: alveolar recruitment strategy applied group; Drug: group without alveolar recruitment strategy

Group 2, lung protective ventilation without alveolar recruitment

In mechanical ventilation volume controlled ventilation (VCV) mode, tidal volume (TV) is 6-8 ml/kg according to ideal body weight, positive end expiratory pressure (PEEP): 8 cmH2O, end tidal carbon dioxide pressure (etCO2): 35-45 mmHg, ventilation will be provided by adjusting the number of breaths.

Device: alveolar recruitment strategy applied group; Drug: group without alveolar recruitment strategy

Interventions

alveolar recruitment strategy applied group DEVICE

the effect of alveolar recruitment strategy on the mechanical parameters of the patients

Group 1, lung protective ventilation with alveolar recruitment; Group 2, lung protective ventilation without alveolar recruitment

group without alveolar recruitment strategy DRUG

effect on mechanical parameters of patients without alveolar recruitment strategy

Group 1, lung protective ventilation with alveolar recruitment; Group 2, lung protective ventilation without alveolar recruitment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: patients undergoing major gynaecooncological surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

As a result of power analysis, the minimum sample size was determined as 16 for each group with an effect size of 1.2, a 5% margin of error and 95% power. We planned 20 patients for each group due to data losses and deficiencies.

You may qualify if:

• Patients with ASAII and III
• BMI\>30 kg/m2 ,\<40 kg/m2
• Patients with an ARISCAT risk score of 26-44

You may not qualify if:

• Patients with an Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk score \> 44
• BMI \> 40 kg/m2 patients

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Duygu Akyol

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.

  PMID: 30260897 BACKGROUND

• Park SH. Perioperative lung-protective ventilation strategy reduces postoperative pulmonary complications in patients undergoing thoracic and major abdominal surgery. Korean J Anesthesiol. 2016 Feb;69(1):3-7. doi: 10.4097/kjae.2016.69.1.3. Epub 2016 Jan 28.

  PMID: 26885294 BACKGROUND

• Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1.

  PMID: 29452815 BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Duygu Akyol

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Akyol

CONTACT

+905447616034; dr.duyguaygun@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)