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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000978662

Enrollment

Registered

2014-09-11

Start date

2012-07-12

Completion date

2013-02-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Laparoscopic surgery is performed by carbon dioxide (CO2) insufflation, but this may induce stress responses. The aim of this study is to compare the level of inflammatory mediators in patients receiving low-VT versus traditional-VT during gynecological laparoscopic surgery. Fourty ASA physical status 1 and 2 subjects older than 18 years-old undergoing laparoscopic gynecological surgery were included. Systemic and pulmonary inflammatory responses (IL6, TNF-alpha, IL8 and IL1B) of patients receiving intraoperative low-VT and traditional-VT during laparoscopic surgery were assessed in blood serum [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 min after tracheal extubation (T3)] and bronchoalveolar lavage (BAL) within T1 and T3. Increase in the serum levels of IL6, TNF-alpha, IL8 and IL1B were observed in both groups during the time periods of T1, T2 and T3.

Interventions

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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)

Outcome results