Impact of lung protective ventilatory strategy on systemic and pulmonary inflammatory responses during laparoscopic surgery: is it really helpful?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000978662
• Date of registration: 11/09/2014
• Prospective Registration: No
• Primary sponsor: Afyon Kocatepe University
• Public title: Impact of lung protective ventilatory strategy on systemic and pulmonary inflammatory responses during laparoscopic surgery: is it really helpful?
• Scientific title: A prospective randomised trial to evaluate the effect of intraoperative tidal volume ventilation with 6ml/kg (Ideal Body weight) and positive end expiratory pressure (PEEP) of 8 cm H2O versus 12ml/kg (Ideal Body weight) on systemic and pulmonary inflammatory responses in adult patients undergoing laparoscopic surgery
• Date of first enrolment: 12/07/2012
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000978662.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: A/Prof ELif Dogan Baki

• Name: A/Prof ELif Dogan Baki

Key inclusion & exclusion criteria

Inclusion criteria: 1-elective laparoscopic gynecological surgery
2- ASA 1-2 patients
Exclusion criteria: 1-history of pulmonary diseases 2- thoracic surgery 3- immune deficiency 4-morbid obesity (body mass index greater than 35) 5-previous history of mechanical ventilation or surgical procedure during general anesthesia (lesser than one year)

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Inflammatory stress in patients undergoing laparoscopic gynaecological surgery;
Inflammatory stress in patients undergoing laparoscopic gynaecological surgery

Anaesthesiology - Other anaesthesiology

Intervention(s)

A 12 ml/kg ventilation (according to ideal height and weight of the patients) and 0 cmH20 PEEP were performed to the patients in group I, 6 ml/kg ventilation (according to ideal height and weight of the patients) and 8 cmH20 PEEP were performed to the patients in group II patients continuously throughout laparoscopic surgery . The ideal body weight of patients was estimated with the formula as follows; 45.5 +/- 0.91 x (cm of height - 152.4)
To assess the systemic inflammatory responses, venous blood samples were taken via veni-puncture. To assess the pulmonary inflammatory responses of both groups, flexible bronchoscopy was performed through the endotracheal intubation tube and bronchoalveolar lavage (BAL) was obtained from right middle lobe or lingula. Second bronchoalveolar lavage was obtained from the contralateral lung (right middle lobe or left lingular segment).

Primary Outcome(s)

inflammatory stress is measured by serum cytokine tumor necrosis factor-alpha, serum Interleukin-1, serum Interleukin 6 and serum Interleukin 8[within the first 5 minutes after endotracheal intubation (T1), 60 minutes after the initiation of mechanical ventilation (T2) and in the postanaesthesia care unit at 30 minute after tracheal extubation (T3)]

Secondary Outcome(s)

inflammatory stress is measured by bronchoalveolar lavage cytokine tumor necrosis factor-alpha , bronchoalveolar lavage Interleukin-1 beta, bronchoalveolar lavage Interleukin 6 and bronchoalveolar lavage Interleukin 8[within the first 5 minutes after endotracheal intubation (T1)and in the postanaesthesia care unit at 30 minute after tracheal extubation (T3)]

Secondary ID(s)

None

Source(s) of Monetary Support

Afyon Kocatepe University