India has close to one lakh ICU beds located in metros and in private hospitals. The Union Health Ministry of India issued revised Guidelines for ICU Admissions and Discharge Criteria (“Guidelines”) on December 23, 2023 drafted under guidance of top 24 doctors panel. The government guidelines for ICU admission outline specific criteria to ensure optimal patient care. The guidelines for the first time define Intensive Care Unit (ICU). The primary criteria for admitting a patient to the ICU are based on organ failure, the need for organ support, or the anticipation of deterioration in the medical condition. The guidelines state the criteria for discharge. Conversely, certain critically ill patients should not be admitted to the ICU, including those who refuse admission, have diseases with treatment limitation plans, possess living wills or advanced directives against ICU care, are terminally ill with a futile medical judgment, or during resource limitations such as a pandemic or disaster.
What does Guidelines say about an ICU?
The guidelines not only define ICU but also provide the criteria for doctors who can be part of ICU and criteria of admission and discharge. The terms Critical Care /Intensive Care/Intensive Therapy Unit are synonymous. It is a designated, specialized area for multidisciplinary, focused management of patients who have life-threatening, partially, or completely reversible organ(s) dysfunction. Such treatment requires continuous and intensive observation and interventions by a multi professional team of appropriately trained healthcare workers including doctors, nurses and other support staff with equipment and paraphernalia necessary for sustaining life until recovery. In accordance with these criteria, ICU admission is warranted in cases of:
- altered level of consciousness,
- hemodynamic instability (such as shock or arrhythmias), and
- the need for respiratory support, including escalating oxygen requirements or
- respiratory failure necessitating non-invasive or invasive ventilation.
- Additionally, patients with severe acute or acute-on-chronic illnesses requiring intensive monitoring or organ support,
- who have experienced major intraoperative complications or undergone major surgeries, fall under the criteria for ICU admission.
The salient points of ICU Discharge
The guidelines also provide criteria for ICU discharge, emphasizing the return of physiological aberrations to near normal or baseline status, reasonable resolution and stability of the acute illness necessitating ICU admission, and patient/family agreement for discharge.
- However, the patients land in ICU due to extensive or irreversible damage and the idea is to prolong life with life support system. Families are integral part of the patient’s health but how far they can be pragmatic in deciding the withdrawal of the life support system and the final decision will not vest with the medical staff can be a matter of further deliberation.
- The Discharge may also be based on a medical decision, avoiding economic constraints, and for infection control or explicit rationing policy reasons. Regarding the infection control there is a caveat in the guidelines for infection control reasons with ensuring appropriate care of the given patient in a non ICU location however, it does not mention who will make satisfaction for the purpose.
Waiting for the ICU Beds
During the crucial time while awaiting an ICU bed, minimum patient monitoring is essential. This includes continuous or intermittent measurements of blood pressure, clinical parameters (such as pulse rate and respiratory rate), heart rate, oxygen saturation (SpO2), capillary refill time, urine output, neurological status (measured by GCS or AVPU scale), intermittent temperature monitoring, and blood sugar levels.
Before transferring a patient to the ICU, certain minimum stabilization measures must be taken. These include ensuring a secure airway (tracheal intubation if the patient has a GCS ≤8), maintaining adequate oxygenation and ventilation, achieving stable hemodynamic with or without vasoactive drug infusion, ongoing correction of hyperglycaemia/hypoglycaemia, and initiation of definitive therapy for life-threatening conditions.
Lastly, when transferring critically ill patients, continuous or intermittent monitoring of blood pressure, clinical parameters, continuous heart rate, and continuous SpO2 is crucial to ensure a seamless transition and ongoing patient safety. These comprehensive guidelines aim to optimize ICU admissions, patient care, and resource utilization.
The following Critically Ill Patients should not be admitted to ICU:
- Patient’s or next–of–kin informed refusal to be admitted in ICU
- Any disease with a treatment limitation plan
- Anyone with a living will or advanced directive against ICU care
- Terminally ill patients with a medical judgement of futility
- Low priority criteria in case of pandemic or disaster situation where there is resource-limitation (e.g. bed, workforce, equipment).
Guiding principles and challenges for the guidelines
The guidelines certainly reflect:
Prioritizing Medical Need:
- Shift from “First-come, First-served“: The focus on organ failure and need for organ support ensures that the most critically ill patients get access to vital resources like ventilators and dialysis machines. This could potentially reduce mortality rates and improve outcomes for those with the highest chance of survival.
Respecting Patient Autonomy:
- Empowering Patients and Families: The emphasis on informed consent and respecting treatment limitation plans and advance directives empowers patients to have a say in their care, particularly during vulnerable times. This shift aligns with evolving ethical considerations in critical care.
- Potential Dilemmas: Navigating situations where patient wishes and medical recommendations differ requires skilful communication and sensitivity from healthcare professionals. Ethical committees might play a crucial role in such cases.
Resource Allocation and Efficiency:
- Addressing Scarcity: By excluding patients with futile care scenarios or low-priority criteria during resource constraints, the guidelines aim to optimize the utilization of limited ICU beds and equipment. This could benefit a larger number of patients in critical situations.
- Equity Concerns: Ensuring fair and equitable access to ICU care across diverse populations becomes even more important with these guidelines. Potential biases based on socioeconomic status or geographical location must be addressed.
Ethical Considerations:
Transparency and Communication: Building trust and understanding through clear communication between doctors and patients/families is crucial. Explaining complex medical decisions and the rationale behind ICU admission or denial requires effective communication skills and empathy.
International Guidelines
Comparing ICU Admission Laws in Europe, the US, and India
India’s recent guidelines on ICU admissions present a structured approach to ethical and resource-efficient critical care. Let’s contrast these guidelines with the established legal frameworks in Europe and the US.
Similarities:
- Patient Autonomy: All regions stress the importance of informed consent from the patient or legal surrogate for ICU admission.
- Medical Need: Prioritization based on the severity of illness and the necessity for critical interventions, such as ventilation or dialysis, is a shared principle.
- Transparency and Communication: Clear communication and explanations to patients and families regarding ICU decisions and alternatives are deemed crucial across all regions.
Differences:
- Explicit Legal Frameworks:
Europe: Several European countries have specific laws addressing ICU admissions, resource allocation, and end-of-life care (e.g., Germany’s Patient Self-Determination Act, Spain’s Law on Autonomy of the Patient).
US: While lacking a single federal law, individual states have statutes and common law principles governing informed consent, medical decision-making, and advance directives.
India: Currently relies on new Health Ministry guidelines, serving as a framework but lacking the legal weight of codified laws.
India has some existing frameworks and regulations influencing critical care admission practices but they were not focused on ICU admission and discharge criteria:
Some of these frameworks are:
- Indian Society of Critical Care Medicine (ISCCM) Guidelines:
Established in 2001 and updated in 2007, these guidelines provided recommendations for ICU planning, design, and resource allocation. Though not legally binding, they were adopted by many hospitals and institutions as a reference point for ICU practices.
- Right to life and patient autonomy:
The Indian Constitution and various legal judgments recognize the right to life and informed consent for medical treatment. These principles influenced how hospitals and healthcare professionals approached critical care decisions, including admission to ICUs.
- Hospital bylaws and policies:
Many hospitals had individual bylaws and internal policies outlining patient care protocols, including criteria for ICU admission and discharge.These policies often took into account resource limitations, ethical considerations, and local needs.
- National Health Mission initiatives:
Various initiatives under the National Health Mission emphasized improving critical care capacity and accessibility. These initiatives sometimes included guidelines or recommendations for ICU practices, though not specifically focused on admission criteria.
- Consent and Surrogacy:
Europe: Some countries permit designated surrogates to make decisions when patients are incapacitated (e.g., Belgium, the Netherlands).
US: State laws vary but generally allow designated surrogates or family members to consent to ICU care if the patient is unable.
India: Similar to the US, legal frameworks typically allow next of kin to consent when patients are unable.
Considerations for India:
- Codifying Guidelines into Law: Establishing a comprehensive legal framework for ICU admissions and resource allocation could enhance clarity and consistency in decision-making.
- Addressing Cultural Sensitivity: Tailoring communication and practices to respect diverse cultural and religious beliefs regarding end-of-life care is crucial.
Public Awareness and Education: Educating healthcare professionals and the public about the new guidelines and their implications for critical care decision-making is imperative.
The Road Ahead:
Implementation and Monitoring: Successful implementation of these guidelines depends on training healthcare professionals, raising public awareness, and establishing robust monitoring mechanisms.
Continuous Improvement: Evolving technologies and medical advancements necessitate regular review and updates of the guidelines to ensure they remain relevant and effective.
In conclusion, the Health Ministry’s new ICU admission guidelines offer a promising framework for ethically sound and resource-efficient critical care in India. However, successful implementation and ongoing dialogue are crucial to ensure equitable access and optimal outcomes for all patients requiring intensive care. There is no mention of the consequences for failure to implement the same as well.