Aims and objectives:

To reduce the unplanned extubation (UE) rates in the NICU by 40% in 6 months after initiation of the study.

This will be a quality improvement (QI) study in which change ideas to decrease unplanned extubation will be tested in multiple plan- do- study- act (PDSA) cycles. Change ideas for processes will be modified suitably and implemented sequentially as individual component or in groups.

The quality improvement study will be conducted in the Neonatal Intensive Care Unit (NICU), Department of Neonatology, Sir Ganga Ram Hospital, New Delhi.

The study population will consist of neonates admitted to NICU:

ï‚·       Inclusion criteria: All neonates admitted to NICU and requiring invasive mechanical ventilation through endo-tracheal tube (ETT) will be included.

ï‚·       Exclusion criteria: Neonates with cranio-facial abnormalities will be excluded. Neonates requiring ventilation through laryngeal mask airway or tracheostomies will be excluded.

The study will be started after clearance from the hospital ethics committee and Clinical Trial Registry of India. It will be continued for 6 months after receiving the approvals. For assessing sustainability surveillance, audits and data collection will continue for a period of another

6 months.

Initiation of the project:

This Quality improvement project will involve systematic implementation of change ideas (outlined in table 1) that will be first rigorously tested in Plan do study act cycles and implemented after suitable modification. A root cause analysis of factors that could cause UE, was performed in our unit by a multidisciplinary team consisting of consultant neonatologists, residents, nurses and respiratory therapists. This has been followed by formation of the multidisciplinary QI team including sister in charge as the leader, two senior nurses, two consultants, two residents and a respiratory therapist. Implementation strategies: Currently, there are no standard ETT securement guidelines in our unit. There is lack of standardization of ETT stabilizing method during insertion and maintenance of ET tube, lack of staff alertness, sedation policy and other factors that may be associated with high rates of UE. Change ideas to improve the processes to decrease UE will be tested in our unit. These change ideas have been planned out after reviewing the literature along with team brainstorming sessions and discussions. These will be tested in a PDSA cycles and would be modified as per the unit requirement, after having reflected on the results and tested again in subsequent PDSA cycles. Once a change idea is consolidated, it would be implemented in the system under the directions of the QI consultant. This would be followed by the testing of another change idea/s and its implementation in a similar fashion.

Change ideas:

A multidisciplinary team was created for quality improvement interventions and included neonatal physicians and nursing staff. They developed change ideas such as

 A.    Optimum Tube Fixation: We have planned to test a few change ideas during fixation of endotracheal tube. These are discussed below-

1.     Training of nurses and resident doctors: Teaching of the healthcare staff would be conducted in different sessions with the help of PowerPoint presentations, and hands- on training would be given to them bedside and on mannequins for fixation of ETT. Video-based tutorial sessions would be conducted regularly every fortnight to educate them about the standardized practices of taping and stabilization of ETT.

2.     Sedation policy during intubation: In our unit, procedural, there is no uniform policy for sedation during elective intubation. We will introduce a sedation policy during intubation of neonates based on recent recommendation.This will be given prior to elective intubations. In neonates with cardio-vascular collapse or crashing neonates, sedation will be avoided. Once the feasibility of sedation policy is tested in PDSA cycle, a compliance audit will be done every fortnight.

3.     Technique of fixation of ETT: The following measures will be introduced in NICU and the compliance of adherence to these methods will be recorded at each intubation episode.

a.      Choosing the correct size of ETT

Weight                        Gestational age                  Endotracheal tube size

Below 1 kg                  Below 28 weeks                 2.5 mm ID

1-2 kg                         28-34 weeks                       3.0 mm ID

Greater than 2 kg       Greater than 34 weeks       3.5 mm ID

 

b.     Nasal-tragus length-based based formula: We will use nasal-tragus length-based formula for determining the depth of ETT insertion in all neonates. This will be documented in nurse’s sheet.

c.      Thread Method: In this method, a thread will be tied with a knot at the cm mark corresponding to depth of ET fixation. The loose ends of the thread will be then fixed with a tegaderm followed by a taping of dynaplast. This method of stabilizing the tube during fixation will be tested in PDSA cycles.

d.     Securing of tapes: Standardized taping method of double Y- and H- configuration would be taught to all the doctors and nursing staff. Both methods will be tested in PDSA cycles. The method found to be effective will

be implemented.

4.     Sticking airway alert cards: Every intubated bed will have an alert card. Alert cards will indicate risk level of UE, the size and depth of ETT insertion and dates of intubation. Moderate risk (Yellow card) will include infants of preterm gestation or those under continuous sedation and without any history of previous unplanned extubation. High alert (Red card) will be stuck on bedside of infants will any prior unplanned extubation or those infants who are agitated or not sedated.

B.    Optimum Tube Maintenance

1.     Training of nurses and resident doctors: Doctors and nursing staff would be taught standardized practices for ETT maintenance and monitoring. This would be done with video-training, hands-on bedside and mannequin experience and educative seminars conducted for the same. Regular education sessions will be incorporated into nursing training on raising awareness of the importance of regular checks, and emphasizing the importance of UE reporting.

2.     Sedation and Restraint during ventilation: A standard policy will be made for use of sedation in the NICU for both term and preterm infants. Use of mittens and practicing swaddling for babies greater than 34 weeks gestational age will be done unless contraindicated or not feasible. These mittens will be removed every 3-4 hours to assess any redness or injury.

3.     Checking tube fixation: The position of fixation of ETT will be checked in each shift during nurses round and will be documented. If tape appears loose or wet or in case the ETT fixation is not at the desired mark, refixation and or taping will be done by two nurses in the presence of a doctor. ETT landmarks would also be assessed and secured whenever the patient is disturbed (eg X-Rays) or after any procedure.

4.     Tube maintenance during procedures: At least two staff members would be providing care to neonates during procedures such as weighing, retaping and securing ETTs, repositioning, transferring the patient out of bed, bathing or linen changes. One provider is solely to stabilize the tube while the procedure is being done, and the other provider can help.

5.     UE event reporting: All unplanned extubation will be reported in a real-time analysis form which is to be completed by the staff caring for the neonates at the time of the event to nurse-in charge and chair-person of the unit. The possible cause of UE will be reviewed and the contributing factors will be assessed. A log book will be introduced for real-time reporting of UE.

Outcome Measures: Unplanned extubation (UE) rates will be calculated every month as:

UE rates per 100 ventilated days = number of UE episodes x 100/ total number of

ventilator days

Process Measures: The following process measures would be calculated every month:

●      Optimal ET fixation bundle compliance defined as presence of all four components -use of proper size, NTL based formula, thread method and H/double-Y taping. Proportion of intubated infants in whom optimum tube fixation bundle compliance was followed will be calculated every month.

●      Risk Alert Card Compliance-Proportion of intubated infants who have an appropriate risk alert card stuck on their cot.

●      Adherence to Sedation and restraint Policy- A weekly audit will be conducted to determine the proportion of infants in whom sedation and restraint policy is followed.

●      Optimal tube maintenance bundle compliance defined as presence of ETT fixed at calculated depth with proper tape which is not loose or wet. Proportion of intubated infants in whom optimum tube maintenance bundle compliance was followed will be calculated every month.

Audits and Compliance check: In the first 2 months after the initiation of the project, baseline data on the UE rates and audit compliance of the bundles will be collected. Fort-nightly compliance of each bundle element and in total would be determined. “Real time” reporting of each UE case will be done. A checklist will be created (Example table 1) for daily monitoring and data recording of all neonates who undergo endotracheal intubation. This will be integrated with nursing charts. Monthly NICU leadership meetings will be held to review the data and guide and facilitate the work of the frontline QI team.

The outcome and process measures will be analysed using QI tools of control charts. A monthly report will be submitted to Quality cell of the hospital.

The quality improvement project will commence after ethical clearance and will be registered with Clinical trial registry of India (CTRI). Waiver of consent will be requested from the Ethics committee.

Table 1. Example of Check list for daily monitoring

Endotracheal Tube Checklist

ï‚·       Fixation checklist

                 I.          Sedation given during intubation (If no mention cause)

                II.          Correct tube size calculated from table

               III.          Correct tube depth determined by NTL

               IV.          Thread method used

                V.          H/Y Strap used

               VI.          Alert Card made and stuck on bedside

ï‚·       Maintenance checklist

                 I.          Tube position and tape checked in each shift

                II.          Physical restraint applied-if not write reason

               III.          Sedation Continuous or intermittent (If not reason)

               IV.          Tube rechecked after X ray or procedure

                V.          Two persons involved during weighing, sponging, linen change or during tube re-fixation.