The PENGUIN trial

PENGUIN: perioperative respiratory care and outcomes for patients undergoing high risk abdominal surgery

PENGUIN is the third global surgical randomised clinical trial following on from the success of FALCON and CHEETAH. PENGUIN aims to reduce Surgical Site Infections (SSI) and pneumonia following abdominal surgery in low and middle-income countries.
Pneumonia and SSI are the most common complications following surgery across the world. They are the commonest healthcare-associated infections in low and middle-income countries, placing significant financial costs on healthcare systems. The increased costs can be a major problem in countries with lower incomes where patients often pay for their own treatment.
PENGUIN is an investigator-initiated and investigator-led trial. PENGUIN is funded by the UK National Institute for Health Research (NIHR).

Aims & Objectives

  • Primary Objective

    The primary objectives of the main RCT is to assess whether preoperative 0.2% chlorhexidine mouthwash reduces the rate of postoperative pneumonia at 30-days compared to no mouthwash, and to assess if 80-100% fraction inspired oxygen (FiO2) used during surgery reduces the rate of postoperative SSI at 30-days compared to 21-30% FiO2.

  • Secondary Objectives

    1. To assess the impact of the interventions on secondary clinical outcomes up to 30 days post-surgery including: mortality rates, repeat abdominal surgery to treat complications (oxygen only), repeat abdominal surgery, length of hospital stay, return to normal activities and admission to z critical care unit.
    2. To explore the impact of the intervention on resource usage and additional costs to the secondary health service provider.
  • The recruitment target is 12,942 participants across all centres

Collaborating countries

PENGUIN is an international trial being conducted in multiple NIHR funded countries. Click on the map below to see participating countries.

Trial summary

Safe and affordable surgery and anaesthesia is a global health priority. There is strong evidence that poor perioperative care is a key factor limiting the net improvements in health which could be achieved through improved global access to surgery. One in six patients experience complications after surgery in LMICs, most commonly infections. Surgical complications reduce life expectancy, quality of life, prevent return to work and cause catastrophic expenditure. For patients undergoing major abdominal surgery, complication rates exceed 30%. Seventy million such procedures are performed worldwide each year (excluding caesarean section) making this the most important global cause of post-operative morbidity and mortality.

An important route of bacterial entry into the lower respiratory tract is aspiration of bacteria in oral and pharyngeal secretions during endotracheal intubation. This results in colonisation of the lower respiratory tract, which overwhelms the patient’s mechanical, humoral, and cellular defences to establish infection following surgery. One potential method to prevent pneumonia after surgery may be to ask patients to use an antiseptic mouthwash with 0.2% chlorhexidine prior to anaesthesia. This treatment is very simple and low in cost, making it ideal for widespread implementation in low and middle-income countries. An international consensus statement from 1,000 anaesthetists, intensive care specialists, surgeons, and epidemiologists identified chlorhexidine mouthwash as a potential inexpensive intervention that may reduce perioperative mortality. However, the statement highlighted the need for effectiveness trials testing chlorhexidine mouthwash before it can be adopted into clinical pathways like perioperative care.

World Health Organisation guidelines recommend the use of liberal inspired oxygen concentrations of 80% during surgery and up to four hours after extubation to help prevent SSI. However, many clinical experts question this recommendation and highlight flaws in the evidence on which it is based. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery. The delivery of high inspired oxygen concentrations during anaesthesia is technically difficult and expensive in resource poor settings. There is also some concern that high inspired oxygen concentrations may even increase mortality amongst acutely ill patients. There is an urgent need for high quality evidence across different s